SMART READ EZTEST STEAM


Device Classification Name

indicator, biological sterilization process

510(k) Number K112018
Device Name SMART READ EZTEST STEAM
Applicant
MESA LABORATORIES, INC.
10 evergreen drive
bozeman, 
MT 
59715

Applicant Contact wendy royalty
Correspondent
MESA LABORATORIES, INC.
10 evergreen drive
bozeman, 
MT 
59715

Correspodent Contact wendy royalty
Regulation Number 880.2800
Classification Product Code
FRC  
Date Received 07/14/2011
Decision Date 01/30/2012
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