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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K012346
Device Name VANGUARD REPROCESSED ARTHROSCOPIC BLADES
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 Number888.1100
Classification Product Code
HRX  
Date Received07/24/2001
Decision Date 10/16/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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