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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intravascular
510(k) Number K954258
Device Name TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION)
Applicant
Gerard Medical Enterprises, Inc.
90 Worcester Rd.
Unit 2, Box 6
Charlton,  MA  01507
Applicant Contact RICHARD CAYER
Correspondent
Gerard Medical Enterprises, Inc.
90 Worcester Rd.
Unit 2, Box 6
Charlton,  MA  01507
Correspondent Contact RICHARD CAYER
Regulation Number880.5965
Classification Product Code
LJT  
Date Received09/05/1995
Decision Date 05/24/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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