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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 K882470
Device Name STERILE DISPOSABLE SURGICAL GOWNS
Applicant
Bolden Products, Div. of the Transport Group
7927 NW 53rd St.
Miami,  FL  33166
Applicant Contact ALEXANDER LUCIO
Correspondent
Bolden Products, Div. of the Transport Group
7927 NW 53rd St.
Miami,  FL  33166
Correspondent Contact ALEXANDER LUCIO
Regulation Number878.4040
Classification Product Code
FYA  
Date Received06/15/1988
Decision Date 08/03/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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