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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 K954489
Device Name TRINITY SLEEVE(S)
Applicant
Delphi Consulting Group
11874 S. Evelyn Cir.
Houston,  TX  77071
Applicant Contact J. HARVEY KNAUSS
Correspondent
Delphi Consulting Group
11874 S. Evelyn Cir.
Houston,  TX  77071
Correspondent Contact J. HARVEY KNAUSS
Regulation Number870.5800
Classification Product Code
JOW  
Date Received09/27/1995
Decision Date 02/22/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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