COMFORT EZ


Device Classification Name

needle, hypodermic, single lumen

510(k) Number K121632
Device Name COMFORT EZ
Applicant
SIMPLE DIAGNOSTICS, INC.
8870 ravello ct
naples, 
FL 
34114

Applicant Contact daniel kamm
Correspondent
SIMPLE DIAGNOSTICS, INC.
8870 ravello ct
naples, 
FL 
34114

Correspodent Contact daniel kamm
Regulation Number 880.5570
Classification Product Code
FMI  
Date Received 06/04/2012
Decision Date 08/10/2012
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