The following data is part of a premarket notification filed by Thermedics, Inc. with the FDA for Peritoneal Dialysis Catheters.
| Device ID | K863128 |
| 510k Number | K863128 |
| Device Name: | PERITONEAL DIALYSIS CATHETERS |
| Classification | Catheter, Peritoneal, Long-term Indwelling |
| Applicant | THERMEDICS, INC. 470 WILDWOOD ST. P.O. BOX 2697 Woburn, MA 01888 -2697 |
| Contact | Robert Murfitt |
| Correspondent | Robert Murfitt THERMEDICS, INC. 470 WILDWOOD ST. P.O. BOX 2697 Woburn, MA 01888 -2697 |
| Product Code | FJS |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-15 |
| Decision Date | 1986-09-09 |