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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Isolation, Surgical
510(k) Number K922442
Device Name ISOLATION GOWNS
Applicant
Pfb Inter-Apparel Corp.
8751 NW 102nd St.
Medley,  FL  33178
Applicant Contact WILHELM E LEMKE
Correspondent
Pfb Inter-Apparel Corp.
8751 NW 102nd St.
Medley,  FL  33178
Correspondent Contact WILHELM E LEMKE
Regulation Number878.4040
Classification Product Code
FYC  
Date Received05/22/1992
Decision Date 10/12/1993
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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