The following data is part of a premarket notification filed by Sil-med Corp. with the FDA for Peritoneal Dialysis Coil Catheter.
| Device ID | K850247 |
| 510k Number | K850247 |
| Device Name: | PERITONEAL DIALYSIS COIL CATHETER |
| Classification | Mask, Surgical |
| Applicant | SIL-MED CORP. 700 WARNER BLVD. Taunton, MA 02780 |
| Contact | Robert Brennan |
| Correspondent | Robert Brennan SIL-MED CORP. 700 WARNER BLVD. Taunton, MA 02780 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-22 |
| Decision Date | 1985-02-14 |