The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Reuse Claim For The Bard Electrophysiology Surelink, Templink, And Templink M Extension Cables.
| Device ID | K013598 |
| 510k Number | K013598 |
| Device Name: | REUSE CLAIM FOR THE BARD ELECTROPHYSIOLOGY SURELINK, TEMPLINK, AND TEMPLINK M EXTENSION CABLES |
| Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
| Applicant | C.R. BARD, INC. 55 TECHNOLOGY DR. Lowell, MA 01851 |
| Contact | Eborah L Herrington |
| Correspondent | Eborah L Herrington C.R. BARD, INC. 55 TECHNOLOGY DR. Lowell, MA 01851 |
| Product Code | DSA |
| CFR Regulation Number | 870.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-31 |
| Decision Date | 2002-01-11 |
| Summary: | summary |