RESERT XL HLD HIGH LEVEL DISINFECTANT


Device Classification Name

sterilant, medical devices

510(k) Number K080420
Device Name RESERT XL HLD HIGH LEVEL DISINFECTANT
Applicant
STERIS Corporation
5960 heisley road
mentor, 
OH 
44060

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

Correspodent Contact john r scoville jr.
Regulation Number 880.6885
Classification Product Code
MED  
Date Received 02/15/2008
Decision Date 09/02/2008
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