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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 K122179
Device Name VASOPRESS DVT LEG GARMENTS (STERILE) VASOPRESS DVT FOOT GARMENTS (STERILE)
Applicant
Compression Therapy Concepts
555 Industrial Way W.
Eatontown,  NJ  07724 -2298
Applicant Contact LEONARD NASS
Correspondent
Compression Therapy Concepts
555 Industrial Way W.
Eatontown,  NJ  07724 -2298
Correspondent Contact LEONARD NASS
Regulation Number870.5800
Classification Product Code
JOW  
Date Received07/23/2012
Decision Date 08/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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