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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vacuum Sample, With Anticoagulant
510(k) Number K951886
Device Name LOK-ON NEEDLE DISPOSAL SYSTEM
Applicant
Becton Dickinson Vacutainer Systems
One Becton Dr.
Franklin Lake,  NJ  07417
Applicant Contact DENISE DUCHENE
Correspondent
Becton Dickinson Vacutainer Systems
One Becton Dr.
Franklin Lake,  NJ  07417
Correspondent Contact DENISE DUCHENE
Regulation Number862.1675
Classification Product Code
GIM  
Subsequent Product Code
KNG  
Date Received04/24/1995
Decision Date 06/30/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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