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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 K895890
Device Name AUTOPEN
Applicant
ULSTER SCIENTIFIC, INC.
P.O. BOX 902
HIGHLAND,  NY  12528
Applicant Contact F CUNNINGHAM
Correspondent
ULSTER SCIENTIFIC, INC.
P.O. BOX 902
HIGHLAND,  NY  12528
Correspondent Contact F CUNNINGHAM
Regulation Number880.5860
Classification Product Code
FMF  
Date Received10/05/1989
Decision Date 02/16/1990
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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