K940864 is an FDA 510(k) clearance for the DENTIST WITH ASSISTANT PACK. This device is classified as a Unit, Operative Dental (Class I - General Controls, product code EIA).
Submitted by Sterile Concepts, Inc. (Richmond, US). The FDA issued a Cleared decision on August 2, 1994, 160 days after receiving the submission on February 23, 1994.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640.
| 510(k) Number | K940864 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 1994 |
| Decision Date | August 02, 1994 |
| Days to Decision | 160 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EIA — Unit, Operative Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6640 |