STERITITE CONTAINER WITH FLASHTITE VALVE PLATE(S) & MEDITRAY PRODUCTS


Device Classification Name

wrap, sterilization

510(k) Number K022978
Device Name STERITITE CONTAINER WITH FLASHTITE VALVE PLATE(S) & MEDITRAY PRODUCTS
Original Applicant
CASE MEDICAL, INC.
65 railroad ave.
ridgefield, 
NJ 
07657 -0402

Original Contact marcia a frieze
Regulation Number 880.6850
Classification Product Code
FRG  
Date Received 09/06/2002
Decision Date 05/09/2003
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