FDA 510(k) Application Details - K043315

Device Classification Name Scalpel, Ultrasonic, Reprocessed

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510(K) Number K043315
Device Name Scalpel, Ultrasonic, 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 000.0000

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Classification Product Code NLQ
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Date Received 12/01/2004
Decision Date 03/22/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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