510(k) K781179
- Device
- Wrench, Gexagon, Driver
- Applicant
- TELECTRONICS, INC.
- 510(k) number
- K781179
- Product code
- DTF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-07-27
- Date received
- 1978-07-14
- Regulation
- 870.3730
- Classification name
- Tools, Pacemaker Service
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 2017865
- 3035553858
- 9617601
- 2182208
- 2023790
- 2649622
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DTF#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K875147 | TORQUE HEX WRENCH | Cardiac Pacemakers, Inc. | 1988-01-27 |