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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrosurgical, cutting & coagulation accessories, laparoscopic & endoscopic, reprocessed
510(k) Number K043198
Device Name VANGUARD REPROCESSED ARTHROSCOPIC WANDS
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
Regulation Number878.4400
Classification Product Code
NUJ  
Date Received11/18/2004
Decision Date 05/27/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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