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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K913114
Device Name TRIM-PORT(TM) IMPLANT ACCESS SYST DUAL TITAN PORT
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 Number880.5860
Classification Product Code
FMF  
Date Received07/08/1991
Decision Date 01/02/1992
Decision Substantially Equivalent - Kit (SESK)
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
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