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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 K942623
Device Name TRIMPORT
Applicant
GERARD MEDICAL ENTERPRISES, INC.
90 WORCESTER RD.
UNIT 2, BOX 6
CHARLTON,  MA  01507
Applicant Contact RICHARD CAYER JR.
Correspondent
GERARD MEDICAL ENTERPRISES, INC.
90 WORCESTER RD.
UNIT 2, BOX 6
CHARLTON,  MA  01507
Correspondent Contact RICHARD CAYER JR.
Regulation Number880.5965
Classification Product Code
LJT  
Date Received05/27/1994
Decision Date 08/23/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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