K974638 is an FDA 510(k) clearance for the STERITITE SEALED CONTAINERS MODEL SCO4Q. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Case Medical, Inc. (Washington, US). The FDA issued a Cleared decision on December 18, 1997, 69 days after receiving the submission on October 10, 1997.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K974638 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 10, 1997 |
| Decision Date | December 18, 1997 |
| Days to Decision | 69 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FRG - Wrap, Sterilization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |