K911118 is an FDA 510(k) clearance for the DTF-1000LL,DTF-1000. This device is classified as a Syringe, Irrigating (dental) (Class I - General Controls, product code EIB).
Submitted by Cp Medical (Huntington Beach, US). The FDA issued a Cleared decision on November 20, 1991, 253 days after receiving the submission on March 12, 1991.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K911118 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 12, 1991 |
| Decision Date | November 20, 1991 |
| Days to Decision | 253 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EIB — Syringe, Irrigating (dental) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |