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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 K925717
Device Name CALF GARMENT DVT10(S) COMPRESSIBLE LIMB SLEEVE
Applicant
HUNTLEIGH HEALTHCARE, INC.
40 CHRISTOPHER WAY
EATONTOWN,  NJ  07724 -3327
Applicant Contact JOANN S HEGARTY
Correspondent
HUNTLEIGH HEALTHCARE, INC.
40 CHRISTOPHER WAY
EATONTOWN,  NJ  07724 -3327
Correspondent Contact JOANN S HEGARTY
Regulation Number870.5800
Classification Product Code
JOW  
Date Received11/12/1992
Decision Date 05/07/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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