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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 K121998
Device Name HM SURGICAL GOWN, NON REINFORCED HM SURGICAL GOWN, FABRIC REINFORCED HM SURGICAL GOWN, POLYERINFORCED
Applicant
CHANGZHOU HOLYMED PRODUCTS CO LTD
528 CHANGWU ROAD SOUTH
WUJIN DISTRICT
CHANGHOU,  CN 213167
Applicant Contact ALAN YU
Correspondent
CHANGZHOU HOLYMED PRODUCTS CO LTD
528 CHANGWU ROAD SOUTH
WUJIN DISTRICT
CHANGHOU,  CN 213167
Correspondent Contact ALAN YU
Regulation Number878.4040
Classification Product Code
FYA  
Date Received07/09/2012
Decision Date 12/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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