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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 K911565
Device Name CUSTOM PROCEDURE TRAY
Applicant
Vanguard Medical Concepts, Inc.
3108 Bruton Rd.
Plant City,  FL  33565
Applicant Contact CHUCK MASEK
Correspondent
Vanguard Medical Concepts, Inc.
3108 Bruton Rd.
Plant City,  FL  33565
Correspondent Contact CHUCK MASEK
Regulation Number878.4370
Classification Product Code
KKX  
Date Received04/09/1991
Decision Date 08/09/1991
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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