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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 K861243
Device Name NEONATAL UNILET
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 Number878.4850
Classification Product Code
FMK  
Date Received04/02/1986
Decision Date 04/29/1986
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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