AMSCO V-PRO 1 AND V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION UNITS


Device Classification Name

sterilizer, chemical

510(k) Number K111810
Device Name AMSCO V-PRO 1 AND V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION UNITS
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 880.6860
Classification Product Code
MLR  
Date Received 06/27/2011
Decision Date 09/02/2011
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