Submission Details
| 510(k) Number | K940749 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 18, 1994 |
| Decision Date | March 28, 1994 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
K940749 is an FDA 510(k) clearance for the LPG 5/10, LPG 10/5, LPG 10/15 AND LPG 15/10, a Alloy, Metal, Base (Class II — Special Controls, product code EJH), submitted by Aalba Dent, Inc. (Chicago, US). The FDA issued a Cleared decision on March 28, 1994, 38 days after receiving the submission on February 18, 1994. This device falls under the Dental review panel. Regulated under 21 CFR 872.3710.
| 510(k) Number | K940749 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 18, 1994 |
| Decision Date | March 28, 1994 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EJH — Alloy, Metal, Base |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.3710 |