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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name scalpel, ultrasonic, reprocessed
510(k) Number K043315
Device Name VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL
Original Applicant
VANGUARD MEDICAL CONCEPTS, INC.
5307 great oak dr.
lakeland,  FL  33815
Original Contact heather crawford
Classification Product Code
NLQ  
Date Received12/01/2004
Decision Date 03/22/2005
Decision substantially equivalent (SE)
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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