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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, hypodermic, single lumen
510(k) Number K021475
Device Name BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET
Applicant
BD
1 BECTON DR. MC 226
FRANKLIN LAKES,  NJ  07417
Applicant Contact PASQUALE AMATO
Correspondent
BD
1 BECTON DR. MC 226
FRANKLIN LAKES,  NJ  07417
Correspondent Contact PASQUALE AMATO
Regulation Number880.5570
Classification Product Code
FMI  
Subsequent Product Codes
FMF   JKA  
Date Received05/08/2002
Decision Date 07/19/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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