K022978 is an FDA 510(k) clearance for the STERITITE CONTAINER WITH FLASHTITE VALVE PLATE(S) & MEDITRAY PRODUCTS. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Case Medical, Inc. (Ridgefield, US). The FDA issued a Cleared decision on May 9, 2003, 245 days after receiving the submission on September 6, 2002.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K022978 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 06, 2002 |
| Decision Date | May 09, 2003 |
| Days to Decision | 245 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRG - Wrap, Sterilization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |