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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 K931091
Device Name DISPOSABLE AMA STERILE DRAPE SHEET, CAT. NO. 5252
Applicant
Alliance Medical, Inc.
Post Office Box 1029
Santa Ynez,  CA  93460
Applicant Contact PAMELA G GOFORTH
Correspondent
Alliance Medical, Inc.
Post Office Box 1029
Santa Ynez,  CA  93460
Correspondent Contact PAMELA G GOFORTH
Regulation Number878.4370
Classification Product Code
KKX  
Date Received03/03/1993
Decision Date 02/03/1994
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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