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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name gown, surgical
510(k) Number K102692
Model MEDIUM, LARGE, EXTRA LARGE, AND EXTRA EXTRA LARGE
Device Name SMS GOWNS (REINFORCED AND REINFORCED WITH GUIDER), SPUNLACE GOWNS (REGULAR, REGULAR WITH GUIDER), SPUNLACE GOWNS (REINFO
Original Applicant
HANGZHOU JINCHENG MEDICAL SUPPLIER MANUFACTURE CO.
5 carey street
pennington,  NJ  08534
Original Contact chengyu shen
Regulation Number878.4040
Classification Product Code
FYA  
Date Received09/20/2010
Decision Date 03/11/2011
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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