STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS


Device Classification Name

wrap, sterilization

510(k) Number K080558
Device Name STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS
Applicant
CASE MEDICAL, INC.
65 railroad ave.
ridgefield, 
NJ 
07657 -0402

Applicant Contact tania lupu
Correspondent
CASE MEDICAL, INC.
65 railroad ave.
ridgefield, 
NJ 
07657 -0402

Correspodent Contact tania lupu
Regulation Number 880.6850
Classification Product Code
FRG  
Date Received 02/28/2008
Decision Date 12/05/2008
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

Recalls CDRH Recalls