K882651 is an FDA 510(k) clearance for the CENTRIX NEEDLETUBE. This device is classified as a Burnisher, Operative (Class I - General Controls, product code EKJ).
Submitted by Centrix, Inc. (Milford, US). The FDA issued a Cleared decision on August 10, 1988, 44 days after receiving the submission on June 27, 1988.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K882651 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 27, 1988 |
| Decision Date | August 10, 1988 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EKJ — Burnisher, Operative |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |