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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 K903364
Device Name GERARD MEDICAL, INC. TRIM-PORT
Applicant
GERARD MEDICAL ENTERPRISES, INC.
P.O. BOX 348
BRIMFIELD,  MA  01010
Applicant Contact CAYER, JR.
Correspondent
GERARD MEDICAL ENTERPRISES, INC.
P.O. BOX 348
BRIMFIELD,  MA  01010
Correspondent Contact CAYER, JR.
Regulation Number880.5965
Classification Product Code
LJT  
Date Received07/26/1990
Decision Date 10/31/1990
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
Recalls CDRH Recalls
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