The following data is part of a premarket notification filed by Sil-med Corp. with the FDA for Sapphire Line Flat Drain/kit With Spi-argent Ii W/or W/out Trocar.
| Device ID | K961295 |
| 510k Number | K961295 |
| Device Name: | SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR |
| Classification | Catheter, Irrigation |
| 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 | GBX |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-04 |
| Decision Date | 1996-06-26 |
| Summary: | summary |