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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Elastic
510(k) Number K013244
Device Name COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE
Applicant
MED GEN, INC.
7284 W. PALMETTO PK. RD.
BOCA RATON,  FL  33433 -3406
Applicant Contact THEDORE BARASH
Correspondent
MED GEN, INC.
7284 W. PALMETTO PK. RD.
BOCA RATON,  FL  33433 -3406
Correspondent Contact THEDORE BARASH
Regulation Number880.5075
Classification Product Code
FQM  
Subsequent Product Code
KYS  
Date Received09/28/2001
Decision Date 12/07/2001
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
Predetermined Change
Control Plan Authorized		 No
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