STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS


Device Classification Name

sterilization wrap containers, trays, cassettes & other accessories

510(k) Number K110682
Device Name STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS
Applicant
CASE MEDICAL, INC.
19 empire blvd
south hackensack, 
NJ 
07606

Applicant Contact tania lupu
Correspondent
CASE MEDICAL, INC.
19 empire blvd
south hackensack, 
NJ 
07606

Correspodent Contact tania lupu
Regulation Number 880.6850
Classification Product Code
KCT  
Date Received 03/10/2011
Decision Date 07/01/2011
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