BROWNE RAPICIDE GLUTARALDEHYDE INDICATOR


Device Classification Name

indicator, physical/chemical sterilization process

510(k) Number K080750
Device Name BROWNE RAPICIDE GLUTARALDEHYDE INDICATOR
Applicant
STERIS Corporation
5960 heisley road
mentor, 
OH 
44060

Applicant Contact john scoville
Correspondent
STERIS Corporation
5960 heisley road
mentor, 
OH 
44060

Correspodent Contact john scoville
Regulation Number 880.2800
Classification Product Code
JOJ  
Date Received 03/17/2008
Decision Date 05/12/2008
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