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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
510(k) Number K012695
Device Name VANGUARD REPROCESSED ARTHROSCOPIC WANDS
Applicant
VANGUARD MEDICAL CONCEPTS, INC.
5307 GREAT OAK DR.
LAKELAND,  FL  33815
Applicant Contact MIKE SAMMON
Correspondent
VANGUARD MEDICAL CONCEPTS, INC.
5307 GREAT OAK DR.
LAKELAND,  FL  33815
Correspondent Contact MIKE SAMMON
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
HRX  
Date Received08/14/2001
Decision Date 10/30/2001
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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