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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K891193
Device Name MEDI-TRACE ACCU-NATE DEVICE
Applicant
Graphic Controls Corp.
189 Van Rensselaer St.
P.O. Box 1274
Buffalo,  NY  14240
Applicant Contact ALBERT J AMELOTTE
Correspondent
Graphic Controls Corp.
189 Van Rensselaer St.
P.O. Box 1274
Buffalo,  NY  14240
Correspondent Contact ALBERT J AMELOTTE
Regulation Number880.5440
Classification Product Code
FPA  
Date Received03/06/1989
Decision Date 09/19/1989
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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