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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stocking, medical support (to prevent pooling of blood in legs)
510(k) Number K122485
Device Name ENCIRCLE COMPRESSION THERAPY STOCKING
Applicant
ENCIRCLE MEDICAL DEVICES LTD.
2400 VIA CARILLO
PALOS VERDES ESTATES,  CA  90274
Applicant Contact SIGI CARON
Correspondent
ENCIRCLE MEDICAL DEVICES LTD.
2400 VIA CARILLO
PALOS VERDES ESTATES,  CA  90274
Correspondent Contact SIGI CARON
Regulation Number880.5780
Classification Product Code
DWL  
Date Received08/14/2012
Decision Date 04/23/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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