K923285 is an FDA 510(k) clearance for the PRO-TIP DISPOSABLE 3/1 SYRINGE NOZZLE. This device is classified as a Unit, Syringe, Air And/or Water (Class I - General Controls, product code ECB).
Submitted by Smith & Nephew, Inc. (Franklin Park, US). The FDA issued a Cleared decision on September 15, 1992, 71 days after receiving the submission on July 6, 1992.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K923285 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 1992 |
| Decision Date | September 15, 1992 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | ECB — Unit, Syringe, Air And/or Water |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |