The following data is part of a premarket notification filed by Case Medical, Inc. with the FDA for Steritite Rigid Reusable Sterilization Container System.
| Device ID | K023614 |
| 510k Number | K023614 |
| Device Name: | STERITITE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM |
| 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 | 2002-10-28 |
| Decision Date | 2003-04-07 |
| Summary: | summary |