BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET


Device Classification Name

needle, hypodermic, single lumen

510(k) Number K021475
Device Name BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET
Original Applicant
BD
1 becton dr. mc 226
franklin lakes, 
NJ 
07417

Original Contact pasquale amato
Regulation Number 880.5570
Classification Product Code
FMI  
Subsequent Product Codes
FMF   JKA  
Date Received 05/08/2002
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