The following data is part of a premarket notification filed by Cordis Webster, Inc. with the FDA for Cordis Webster Ref-star External Reference Patch, Model # D-1210.
| Device ID | K982415 |
| 510k Number | K982415 |
| Device Name: | CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210 |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | CORDIS WEBSTER, INC. 4750 LITTLEJOHN ST. Baldwin Park, CA 91706 |
| Contact | Mary Adams |
| Correspondent | Mary Adams CORDIS WEBSTER, INC. 4750 LITTLEJOHN ST. Baldwin Park, CA 91706 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-13 |
| Decision Date | 1998-08-10 |
| Summary: | summary |