The following data is part of a premarket notification filed by Pace Medical with the FDA for Disposable Surgical Extension Cable, Model 4255 And Model 4260.
| Device ID | K012392 |
| 510k Number | K012392 |
| Device Name: | DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260 |
| Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
| Applicant | PACE MEDICAL 391 TOTTEN POND RD. Waltham, MA 02451 |
| Contact | Robert C Mace |
| Correspondent | Robert C Mace PACE MEDICAL 391 TOTTEN POND RD. Waltham, MA 02451 |
| Product Code | DSA |
| CFR Regulation Number | 870.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-27 |
| Decision Date | 2001-09-04 |