DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM


Device Classification Name

pump, infusion, elastomeric

510(k) Number K072921
Device Name DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM
Applicant
SYMBIOS MEDICAL PRODUCTS, LLC
7301 georgetown rd
suite 150
indianapolis, 
IN 
46268 -4194

Applicant Contact jeffrey alholm
Correspondent
SYMBIOS MEDICAL PRODUCTS, LLC
7301 georgetown rd
suite 150
indianapolis, 
IN 
46268 -4194

Correspodent Contact jeffrey alholm
Regulation Number 880.5725
Classification Product Code
MEB  
Subsequent Product Codes
BSO   KGZ  
Date Received 10/15/2007
Decision Date 11/26/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls