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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 K932725
Device Name B-D ULTRA FINE(R) LANCET
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1 BECTON DR.
FRANKLIN LAKES,  NJ  07417 -1880
Applicant Contact RUSSELL ARNSBERGER
Correspondent
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1 BECTON DR.
FRANKLIN LAKES,  NJ  07417 -1880
Correspondent Contact RUSSELL ARNSBERGER
Regulation Number878.4850
Classification Product Code
FMK  
Date Received06/07/1993
Decision Date 07/23/1993
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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