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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sleeve, Limb, Compressible
510(k) Number K012403
Device Name VANGUARD REPROCESSED COMPRESSION GARMENT
Applicant
VANGUARD MEDICAL CONCEPTS, INC.
5307 GREAT OAK DR.
LAKELAND,  FL  33815
Applicant Contact MICHAEL SAMMON
Correspondent
VANGUARD MEDICAL CONCEPTS, INC.
5307 GREAT OAK DR.
LAKELAND,  FL  33815
Correspondent Contact MICHAEL SAMMON
Regulation Number870.5800
Classification Product Code
JOW  
Date Received07/30/2001
Decision Date 10/17/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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