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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 K945250
Device Name TRIMPORT
Applicant
Gerard Medical Enterprises, Inc.
90 Worcester Rd.
Charlton,  MA  01507
Correspondent
Gerard Medical Enterprises, Inc.
90 Worcester Rd.
Charlton,  MA  01507
Regulation Number880.5965
Classification Product Code
LJT  
Date Received10/28/1994
Decision Date 03/07/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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