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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 K080627
Device Name PROMEDICAL SURGICAL GOWNS, MODELS: 1002494A, 100770A
Applicant
Promedical Products Co., Ltd.
# 206 Haung He Rd. W.
Changzhou, Jiangsu,  CN 213022
Applicant Contact LEO WEI
Correspondent
Promedical Products Co., Ltd.
# 206 Haung He Rd. W.
Changzhou, Jiangsu,  CN 213022
Correspondent Contact LEO WEI
Regulation Number878.4040
Classification Product Code
FYA  
Date Received03/05/2008
Decision Date 04/24/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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