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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, Electric, Reprocessed
510(k) Number K011800
Device Name VANGUARD REPROCESSED ELECTRIC BIOPSY FORCEPS
Applicant
Vanguard Medical Concepts, Inc.
5307 Great Oak Dr.
Lakeland,  FL  33815
Applicant Contact MIKE SAMMON
Correspondent
Vanguard Medical Concepts, Inc.
5307 Great Oak Dr.
Lakeland,  FL  33815
Correspondent Contact MIKE SAMMON
Regulation Number876.4300
Classification Product Code
NLU  
Date Received06/08/2001
Decision Date 09/27/2001
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
Predetermined Change
Control Plan Authorized		 No
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