The following data is part of a premarket notification filed by Sil-med Corp. with the FDA for Mediastinal Silicone Drains.
| Device ID | K942709 |
| 510k Number | K942709 |
| Device Name: | MEDIASTINAL SILICONE DRAINS |
| Classification | Catheter, Peritoneal |
| Applicant | SIL-MED CORP. 700 WARNER BLVD. Taunton, MA 02780 |
| Contact | Karen Sylvia |
| Correspondent | Karen Sylvia SIL-MED CORP. 700 WARNER BLVD. Taunton, MA 02780 |
| Product Code | GBW |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-08 |
| Decision Date | 1996-01-04 |