用于牙科骨移植材料器械的动物研究-上市前通知(510(k))提交资料

薛定谔的龙猫 2025-11-11 23 3.02MB 17 页 150质量币
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Contains Nonbinding Recommendations
󵰩󳖏󵥚󶃒󸆩󶃼󵀎󴹑󴲚󳵩󴾱󵶅󳦩󵥪
󵼕󶅷 - 󳔋󴔃󳥎󷜛󵻦󾘉510(k)󾘊󴫑
󳖥󷑅󴲚
󶽍󳔛󴨈󳩘󳫋󷿠󳯂󶩰󳯂󵷒󵹤󶊢󵬇
󴍁󴓦󳙝󳖻󳭙󴨈󳩘
2025 󴕵 8 󴸉 22 󴳦󶉿󳫒󵶅󴲈󳗷󱜃
󴸭󴲈󳗷󵶅󶩊󴽉󳖏 2024 󴕵 3 󴸉 29 󴳦󳫒󴔄󱜃
󴸊󳡴󴸭󴲈󳗷󵶅󷳯󷾙󾘍󷋸󶣵󵰶 󾘉301󾘊 796-5620 󶝕󶏼 OHT1󾘛󵸽󶃒󱜂󸖼󷢊󱜂󳭽󳬹󱜂
󶜴󸘼󳲊󳫋󵥚󶃒󳵩󴾱󳦟󳡭󴊥/DHT1B󾘛󵥚󶃒󳫋󶜴󸘼󳲊󳵩󴾱󴀅󱜃
󶚏󳷾󳩬󵰠󳔏󳡭󳘘󴸎󳦢󷟩󷿠󳯂󶩰󳯂󵷒󵹤󶊢󵬇
󴍁
󳵩󴾱󳔏󴰿󴌅󳝦󴖸󳔮󴛄
Contains Nonbinding Recommendations
󴖐󷄁
󳡭󳘘󷋅󷊻
󴞩󳫰󷶐󴳷󷜛󷛈 https://www.regulations.gov 󳬒󴸭󴸻󴺅󴫑󳖥󵰶󴉑󴠐󷃂󳮍󴗻󷊯󱜃󳕧󷹣󴠐
󷃂󷋸󴋅󶣴󸅭󷣍󳡱󴓟󶙘󳡌󶗵󴌕󴔃󷐺󴔍󴌕󷓰 5630 󳫸 1061 󴊥󾘉HFA-305󾘊󾘍󷿠󳯂󳮍󶩰
󵥪󶊢󵬇󴍁󴽤󴽉󶊢󵬇󴀅󾘍󷞯󶘗 20852-1740󱜃󷋸󳸩󴥁󴸊󴠐󷃂󳔮󵏩󴴏󴽤󴽉󶘗󳫸 FDA-
2024-D-1242󱜃󳸩󴸭󴲈󳗷󳔌󵈢󳛯󷊣󴤗󴷵󴲱󳕌󳥎󾘍󴸭󴸻󴺅󳔎󳘛󴋺󴠐󷃂󷣈󳫗󶽍󳦩󱜃
󷵅󳦡󳥰󴸭
󴞩󷛙󳫰󳗦󳗏󳖓󶝕󶙒󶪸󳫗󴷵󴀛󳥰󴸭󱜃󴞩󳕠󳫰󳗦󳬒 CDRH-Guidance@fda.hhs.gov 󳫒󷜂
󵰶󴉑󷞯󳗷󷋸󵍃󶪸󳫗󷋦󴨈󳩘󵶅󳥰󴸭󱜃󷋸󳸩󷋸󵍃󳔮󵏩󴴏󴲈󳗷󶘗󳫸 GUI00007042 󳗦󳫋󴨈
󳩘󵶅󴊍󴱵󴼈󷾙󱜃
Contains Nonbinding Recommendations
󵷯󴙖
󴤒. 󳗌󶗎............................................................................................................................................ 1
II. 󶟍󴵰 ........................................................................................................................................... 2
3󱜃󶨄󳷵.............................................................................................................................................. 3
IV. 510(k) 󴫑󳖥󴗻󷊯 ........................................................................................................................ 4
A. 󳦩󵥪󵼕󶅷................................................................................................................................ 4
󳦩󵥪󵄢󳺌 ...................................................................................................................... 4
󵼕󶅷󷊿󷊢󶜄󷣐 ............................................................................................................. 5
B. 󳡷󳗗󶜄󶵒󳷡󶐡 ...................................................................................................................... 12
摘要:

ContainsNonbindingRecommendationsuNrYyyigPeVhhvRrixzvNRMw510kcNDeLNcSWSToTvwctONTXcSW2025t8g22eSveN0geNvIhHN2024t3g29eS0gQsgeNvu53017965620TOHT1wy00TT803USrYyVhhRQlDHT1BrYyS3UVhhY0VSkuNQlOgRToTvwctVhhNePeNContainsNonbindingRecommendationsQlOSehttpswwwregulationsgovTgggcNu5PaT0NfbalQpWQK95630S1061HFA...

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用于牙科骨移植材料器械的动物研究-上市前通知(510(k))提交资料.pdf

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作者:薛定谔的龙猫 分类:专业资料 价格:150质量币 属性:17 页 大小:3.02MB 格式:PDF 时间:2025-11-11
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