K781179 is an FDA 510(k) clearance for the WRENCH, GEXAGON, DRIVER. This device is classified as a Tools, Pacemaker Service (Class I - General Controls, product code DTF).
Submitted by Telectronics, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 27, 1978, 13 days after receiving the submission on July 14, 1978.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3730.
| 510(k) Number | K781179 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 14, 1978 |
| Decision Date | July 27, 1978 |
| Days to Decision | 13 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DTF — Tools, Pacemaker Service |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 870.3730 |