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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 K942620
Device Name FEATHER-TOUCH SINGLE-STICK DEVICE
Applicant
ULSTER SCIENTIFIC, INC.
P.O. BOX 819
NEW PALTZ,  NY  12561 -0819
Applicant Contact DANIEL A GRAFF
Correspondent
ULSTER SCIENTIFIC, INC.
P.O. BOX 819
NEW PALTZ,  NY  12561 -0819
Correspondent Contact DANIEL A GRAFF
Regulation Number878.4850
Classification Product Code
FMK  
Date Received06/02/1994
Decision Date 06/22/1994
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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