ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KIT, ACCUFUSER INFUSION KIT


Device Classification Name

pump, infusion, elastomeric

510(k) Number K023098
Device Name ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KIT, ACCUFUSER INFUSION KIT
Original Applicant
MCKINLEY INFUSER
631 howard #202
san francisco, 
CA 
94105

Original Contact john chappell
Regulation Number 880.5725
Classification Product Code
MEB  
Date Received 09/18/2002
Decision Date 12/09/2002
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