CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SYRINGE KIT


Device Classification Name

anesthesia conduction kit

510(k) Number K110053
Device Name CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SYRINGE KIT
Applicant
SMITHS MEDICAL ASD, INC.
10 bowman dr.
keene, 
NH 
03431

Applicant Contact cindy engelhardt
Correspondent
SMITHS MEDICAL ASD, INC.
10 bowman dr.
keene, 
NH 
03431

Correspodent Contact cindy engelhardt
Regulation Number 868.5140
Classification Product Code
CAZ  
Date Received 01/07/2011
Decision Date 09/14/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No