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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
510(k) Number K894474
Device Name THE AUTOLET LITE
Applicant
ULSTER SCIENTIFIC, INC.
P.O. BOX 902
HIGHLAND,  NY  12528
Applicant Contact ROBERT E SHAW
Correspondent
ULSTER SCIENTIFIC, INC.
P.O. BOX 902
HIGHLAND,  NY  12528
Correspondent Contact ROBERT E SHAW
Regulation Number878.4850
Classification Product Code
FMK  
Date Received07/18/1989
Decision Date 08/18/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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