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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Restraint, Protective
510(k) Number K013239
Device Name COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES
Applicant
MED GEN, INC.
7284 W. PALMETTO PK. RD.
BOCA RATON,  FL  33433 -3406
Applicant Contact THEODORE BARASH
Correspondent
MED GEN, INC.
7284 W. PALMETTO PK. RD.
BOCA RATON,  FL  33433 -3406
Correspondent Contact THEODORE BARASH
Regulation Number880.6760
Classification Product Code
FMQ  
Date Received09/28/2001
Decision Date 11/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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