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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 K922147
Device Name DUAL PLASTIC VASCULAR ACCESS SYSTEM
Applicant
GERARD MEDICAL ENTERPRISES, INC.
90 WORCESTER RD.
UNIT 2, BOX 6
CHARLTON,  MA  01507
Applicant Contact CAYER, JR.
Correspondent
GERARD MEDICAL ENTERPRISES, INC.
90 WORCESTER RD.
UNIT 2, BOX 6
CHARLTON,  MA  01507
Correspondent Contact CAYER, JR.
Regulation Number880.5965
Classification Product Code
LJT  
Date Received05/07/1992
Decision Date 12/04/1992
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
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