BROWNE OPA TEST STRIP


Device Classification Name

indicator, physical/chemical sterilization process

510(k) Number K081427
Device Name BROWNE OPA TEST STRIP
Applicant
STERIS Corporation
5960 heisley road
mentor, 
OH 
44060

Applicant Contact robert sullivan
Correspondent
STERIS Corporation
5960 heisley road
mentor, 
OH 
44060

Correspodent Contact robert sullivan
Regulation Number 880.2800
Classification Product Code
JOJ  
Date Received 05/21/2008
Decision Date 06/11/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No