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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 K061814
Device Name VASOPRESS DVT SYSTEM, MODEL VP500D
Applicant
Compression Therapy Concepts, Inc.
1750 Brielle Ave. Suite B6
Wanamassa,  NJ  07712
Applicant Contact LEONARD NASS
Correspondent
Compression Therapy Concepts, Inc.
1750 Brielle Ave. Suite B6
Wanamassa,  NJ  07712
Correspondent Contact LEONARD NASS
Regulation Number870.5800
Classification Product Code
JOW  
Date Received06/27/2006
Decision Date 11/30/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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