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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 K983680
Device Name TRINITY II SINGLE CHAMBER DVT PUMP
Applicant
DELPHI CONSULTING GROUP
11874 SOUTH EVELYN CIRCLE
HOUSTON,  TX  77071
Applicant Contact J. HARVEY KNAUSS
Correspondent
DELPHI CONSULTING GROUP
11874 SOUTH EVELYN CIRCLE
HOUSTON,  TX  77071
Correspondent Contact J. HARVEY KNAUSS
Regulation Number870.5800
Classification Product Code
JOW  
Date Received10/20/1998
Decision Date 04/28/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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