INSULIN PROTECTOR


Device Classification Name

adaptor, holder, syringe

510(k) Number K073555
Device Name INSULIN PROTECTOR
Applicant
MEDICOOL, INC.
20460 gramercy pl.
torrance, 
CA 
90501

Applicant Contact eugene chang
Correspondent
MEDICOOL, INC.
20460 gramercy pl.
torrance, 
CA 
90501

Correspodent Contact eugene chang
Regulation Number 890.5050
Classification Product Code
IQG  
Date Received 12/18/2007
Decision Date 07/11/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No