The following data is part of a premarket notification filed by Webster Laboratories, Inc. with the FDA for Electrode Catheter, Orthogonal Type.
| Device ID | K841802 |
| 510k Number | K841802 |
| Device Name: | ELECTRODE CATHETER, ORTHOGONAL TYPE |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | WEBSTER LABORATORIES, INC. P.O. BOX 237 Altadena, CA 91001 |
| Contact | Jim Tyberg |
| Correspondent | Jim Tyberg WEBSTER LABORATORIES, INC. P.O. BOX 237 Altadena, CA 91001 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-01 |
| Decision Date | 1984-10-18 |