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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 K112838
Device Name VASOPRESS REPROCESSED DVT LEG / FOOT GARMENTS
Applicant
Compression Therapy Concepts, Inc.
35 James Way
Eatontown,  NJ  07724
Applicant Contact LEONARD NASS
Correspondent
Compression Therapy Concepts, Inc.
35 James Way
Eatontown,  NJ  07724
Correspondent Contact LEONARD NASS
Regulation Number870.5800
Classification Product Code
JOW  
Date Received09/28/2011
Decision Date 11/10/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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