K885075 is an FDA 510(k) clearance for the ABIOMED PERIOTEMP(TM) PROBE. This device is classified as a Gauge, Depth, Instrument, Dental (Class I - General Controls, product code EIL).
Submitted by Abiomed, Inc. (Danvers, US). The FDA issued a Cleared decision on February 13, 1989, 67 days after receiving the submission on December 8, 1988.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K885075 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 08, 1988 |
| Decision Date | February 13, 1989 |
| Days to Decision | 67 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | - |
| Product Code | EIL - Gauge, Depth, Instrument, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |