STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR


Device Classification Name

indicator, biological sterilization process

510(k) Number K111150
Device Name STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR
Applicant
STERITEC PRODUCTS MFG. CO., INC.
74 inverness drive east
englewood, 
CO 
80112

Applicant Contact jonathan rutigliano
Correspondent
STERITEC PRODUCTS MFG. CO., INC.
74 inverness drive east
englewood, 
CO 
80112

Correspodent Contact jonathan rutigliano
Regulation Number 880.2800
Classification Product Code
FRC  
Date Received 04/25/2011
Decision Date 07/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls