510(k) K875147
- Device
- TORQUE HEX WRENCH
- Applicant
- CARDIAC PACEMAKERS, INC.
- 510(k) number
- K875147
- Product code
- DTF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-01-27
- Date received
- 1987-12-15
- 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#
- Contact
- GREG MATHISON
- Address
- 4100 Hamline Ave., N. P.O. Box 64079 St. Paul MN US 55112 55112
FDA Registration Numbers#
- 2023790
- 3035553858
- 2649622
- 9617601
- 2182208
- 2017865
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DTF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K781179 | WRENCH, GEXAGON, DRIVER | Telectronics, Inc. | 1978-07-27 |
Legacy Summary#
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FDA Review#
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