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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name forceps, biopsy, non-electric, reprocessed
510(k) Number K042594
Device Name VANGUARD REPROCESSED NON-ELECTRIC BIOPSY FORCEPS
Applicant
VANGUARD MEDICAL CONCEPTS, INC.
5307 GREAT OAK DR.
LAKELAND,  FL  33815
Applicant Contact HEATHER CRAWFORD
Correspondent
VANGUARD MEDICAL CONCEPTS, INC.
5307 GREAT OAK DR.
LAKELAND,  FL  33815
Correspondent Contact HEATHER CRAWFORD
Regulation Number876.1075
Classification Product Code
NON  
Date Received09/23/2004
Decision Date 01/25/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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