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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 K103187
Device Name TRIPLEPLAY-VT VASCULAR THERAPY SYSTEM
Applicant
Wildcat Medical, Inc.
284 Ridge Rd.
Hinckley,  OH  44233
Applicant Contact JOE ADKINS
Correspondent
Wildcat Medical, Inc.
284 Ridge Rd.
Hinckley,  OH  44233
Correspondent Contact JOE ADKINS
Regulation Number870.5800
Classification Product Code
JOW  
Date Received10/28/2010
Decision Date 01/26/2011
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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