BD ORAL/ENTERAL SYRINGE WITH BD UNIVIA CONNECTION


Device Classification Name

tubes, gastrointestinal (and accessories)

510(k) Number K112434
Device Name BD ORAL/ENTERAL SYRINGE WITH BD UNIVIA CONNECTION
Applicant
BD MEDICAL SURGICAL
one becton dr. mc237
franklin lakes, 
NJ 
07417 -1880

Applicant Contact john roberts
Correspondent
BD MEDICAL SURGICAL
one becton dr. mc237
franklin lakes, 
NJ 
07417 -1880

Correspodent Contact john roberts
Regulation Number 876.5980
Classification Product Code
KNT  
Date Received 08/24/2011
Decision Date 09/29/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No