VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION PROCESSES


Device Classification Name

indicator, physical/chemical sterilization process

510(k) Number K103331
Device Name VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION PROCESSES
Applicant
STERIS Corporation
5960 heisley road
mentor, 
OH 
44060

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

Correspodent Contact robert f sullivan
Regulation Number 880.2800
Classification Product Code
JOJ  
Date Received 11/12/2010
Decision Date 09/01/2011
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