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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
510(k) Number K003670
Device Name PATIENT DRAPE, SURGICAL
Applicant
Advance Medical Designs, Inc.
1241 Atlanta Industrial Dr.
Marietta,  GA  30066
Applicant Contact BILL GILL
Correspondent
Advance Medical Designs, Inc.
1241 Atlanta Industrial Dr.
Marietta,  GA  30066
Correspondent Contact BILL GILL
Regulation Number878.4370
Classification Product Code
KKX  
Date Received11/28/2000
Decision Date 01/26/2001
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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