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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 K091097
Device Name PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501
Applicant
Promedical Products Co., Ltd.
5165 Broadway
Suite 116
Depew,  NY  14043
Applicant Contact DAVID POWER
Correspondent
Promedical Products Co., Ltd.
5165 Broadway
Suite 116
Depew,  NY  14043
Correspondent Contact DAVID POWER
Regulation Number878.4040
Classification Product Code
FYA  
Date Received04/16/2009
Decision Date 05/27/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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