The following data is part of a premarket notification filed by Sil-med Corp. with the FDA for Antimicrobial Peritoneal Dialysis Coil Catheter With Spi-argent Ii.
| Device ID | K961392 |
| 510k Number | K961392 |
| Device Name: | ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II |
| Classification | Catheter, Peritoneal, Long-term Indwelling |
| Applicant | SIL-MED CORP. 700 WARNER BLVD. Taunton, MA 02780 |
| Contact | Karen K Sylvia |
| Correspondent | Karen K Sylvia SIL-MED CORP. 700 WARNER BLVD. Taunton, MA 02780 |
| Product Code | FJS |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-11 |
| Decision Date | 1997-07-18 |
| Summary: | summary |