FDA 510(k) Application Details - K042594

Device Classification Name Forceps, Biopsy, Non-Electric, Reprocessed

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510(K) Number K042594
Device Name Forceps, Biopsy, Non-Electric, Reprocessed
Applicant VANGUARD MEDICAL CONCEPTS, INC.
5307 GREAT OAK DR.
LAKELAND, FL 33815 US
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Contact HEATHER CRAWFORD
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Regulation Number 876.1075

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Classification Product Code NON
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Date Received 09/23/2004
Decision Date 01/25/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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