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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Syringe Needle
510(k) Number K860284
Device Name DIAMATIC, AUTOMATIC INSULIN INJECTOR
Applicant
ULSTER SCIENTIFIC, INC.
P.O. BOX 902
HIGHLAND,  NY  12528
Applicant Contact ROBERT K MCEWEN
Correspondent
ULSTER SCIENTIFIC, INC.
P.O. BOX 902
HIGHLAND,  NY  12528
Correspondent Contact ROBERT K MCEWEN
Regulation Number880.6920
Classification Product Code
KZH  
Date Received01/28/1986
Decision Date 04/07/1986
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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