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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical, Antimicrobial
510(k) Number K904957
Device Name STERILE AND NON-STERILE TEXTILE PACKS
Applicant
Surgical Pack Services, Inc.
220 S. 38th St.
Birmingham,  AL  35222
Applicant Contact BARTON TATE
Correspondent
Surgical Pack Services, Inc.
220 S. 38th St.
Birmingham,  AL  35222
Correspondent Contact BARTON TATE
Regulation Number878.4370
Classification Product Code
KKX  
Date Received11/05/1990
Decision Date 02/21/1991
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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