BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344, 367336, 367342, 367335, 367341


Device Classification Name

tubes, vials, systems, serum separators, blood collection

510(k) Number K030573
Device Name BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344, 367336, 367342, 367335, 367341
Applicant
BD VACUTAINER SYSTEMS PREANALYICAL SOLUTIONS
1 becton dr., becton bldg.
franklin lakes, 
NJ 
07417 -1885

Applicant Contact m. wendy ballesteros
Correspondent
BD VACUTAINER SYSTEMS PREANALYICAL SOLUTIONS
1 becton dr., becton bldg.
franklin lakes, 
NJ 
07417 -1885

Correspodent Contact m. wendy ballesteros
Regulation Number 862.1675
Classification Product Code
JKA  
Subsequent Product Code
FPA  
Date Received 02/24/2003
Decision Date 05/08/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No