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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 K061967
Device Name SCD GARMENT, MODEL VP530
Applicant
Compression Therapy Concepts, Inc.
1750 Brielle Ave. Suite B6
Wanamassa,  NJ  07712
Applicant Contact LEN NASS
Correspondent
Compression Therapy Concepts, Inc.
1750 Brielle Ave. Suite B6
Wanamassa,  NJ  07712
Correspondent Contact LEN NASS
Regulation Number870.5800
Classification Product Code
JOW  
Date Received07/12/2006
Decision Date 09/25/2006
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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