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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name single-use reprocessed ultrasonic surgical instruments
510(k) Number K043315
Device Name VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL
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
Classification Product Code
NLQ  
Date Received12/01/2004
Decision Date 03/22/2005
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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