K973248 is an FDA 510(k) clearance for the IMTEC BONE COLLECTOR SYSTEM. This device is classified as a Evacuator, Oral Cavity (Class I - General Controls, product code EHZ).
Submitted by Imtec Corp. (Ardmore, US). The FDA issued a Cleared decision on November 19, 1997, 82 days after receiving the submission on August 29, 1997.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640.
| 510(k) Number | K973248 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 1997 |
| Decision Date | November 19, 1997 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EHZ — Evacuator, Oral Cavity |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6640 |