BD INSYTE AUTOGUARD BC


Device Classification Name

catheter,intravascular,therapeutic,short-term less than 30 days

510(k) Number K110443
Device Name BD INSYTE AUTOGUARD BC
Applicant
BECTON DICKINSON & CO.
9450 south state street
sandy, 
UT 
84070

Applicant Contact rand pugmire
Correspondent
BECTON DICKINSON & CO.
9450 south state street
sandy, 
UT 
84070

Correspodent Contact rand pugmire
Regulation Number 880.5200
Classification Product Code
FOZ  
Date Received 02/16/2011
Decision Date 07/19/2011
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