The following data is part of a premarket notification filed by Cardiac Pacemakers, Inc. with the FDA for Torque Hex Wrench.
| Device ID | K875147 |
| 510k Number | K875147 |
| Device Name: | TORQUE HEX WRENCH |
| Classification | Tools, Pacemaker Service |
| Applicant | CARDIAC PACEMAKERS, INC. 4100 HAMLINE AVE., NORTH P.O. BOX 64079 St. Paul, MN 55112 -5798 |
| Contact | Greg Mathison |
| Correspondent | Greg Mathison CARDIAC PACEMAKERS, INC. 4100 HAMLINE AVE., NORTH P.O. BOX 64079 St. Paul, MN 55112 -5798 |
| Product Code | DTF |
| CFR Regulation Number | 870.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-15 |
| Decision Date | 1988-01-27 |