K953068 is an FDA 510(k) clearance for the OXBORO-MEDICAL FOAM INSTRUMENT HOLDER. 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 January 23, 1996, 207 days after receiving the submission on June 30, 1995.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K953068 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 1995 |
| Decision Date | January 23, 1996 |
| Days to Decision | 207 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 |