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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 K920562
Device Name UNISTIK
Applicant
ULSTER SCIENTIFIC, INC.
P.O. BOX 819
NEW PALTZ,  NY  12561 -0819
Applicant Contact ROBERT E SHAW
Correspondent
ULSTER SCIENTIFIC, INC.
P.O. BOX 819
NEW PALTZ,  NY  12561 -0819
Correspondent Contact ROBERT E SHAW
Regulation Number878.4850
Classification Product Code
FMK  
Date Received02/06/1992
Decision Date 03/27/1992
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
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