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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 K912111
Device Name MODIFIED VERSION IMPLANTABLE VASCULAR ACCESS SYSTE
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 Number880.5860
Classification Product Code
FMF  
Date Received05/13/1991
Decision Date 10/08/1991
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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