STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPE


Device Classification Name

indicator, physical/chemical sterilization process

510(k) Number K122555
Device Name STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPE
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
JOJ  
Date Received 08/22/2012
Decision Date 12/12/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Abbreviated
Reviewed by Third Party No

Combination Product

No