The following data is part of a premarket notification filed by Case Medical, Inc. with the FDA for Steritite Container With Flashtite Valve Plate(s) & Meditray Products.
Device ID | K022978 |
510k Number | K022978 |
Device Name: | STERITITE CONTAINER WITH FLASHTITE VALVE PLATE(S) & MEDITRAY PRODUCTS |
Classification | Wrap, Sterilization |
Applicant | CASE MEDICAL, INC. 65 RAILROAD AVE. Ridgefield, NJ 07657 -0402 |
Contact | Marcia A Frieze |
Correspondent | Tania Lupu CASE MEDICAL, INC. 65 RAILROAD AVE. Ridgefield, NJ 07657 -0402 |
Product Code | FRG |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-09-06 |
Decision Date | 2003-05-09 |
Summary: | summary |