K952787 is an FDA 510(k) clearance for the FOAM INSTRUMENT GUARD. This device is classified as a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II - Special Controls, product code KCT).
Submitted by Oxboro Medical Intl., Inc. (Ham Lake, US). The FDA issued a Cleared decision on December 28, 1995, 192 days after receiving the submission on June 19, 1995.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K952787 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 19, 1995 |
| Decision Date | December 28, 1995 |
| Days to Decision | 192 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | KCT — Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |