VERIFY SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACK


Device Classification Name

indicator, biological sterilization process

510(k) Number K073618
Device Name VERIFY SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACK
Applicant
STERIS Corporation
5960 heisley road
mentor, 
OH 
44060

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

Correspodent Contact john r scoville
Regulation Number 880.2800
Classification Product Code
FRC  
Date Received 12/26/2007
Decision Date 01/07/2009
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