The following data is part of a premarket notification filed by Sil-med Corp. with the FDA for Silicone Sump Drain.
| Device ID | K862767 |
| 510k Number | K862767 |
| Device Name: | SILICONE SUMP DRAIN |
| Classification | Catheter, Ventricular, General & Plastic Surgery |
| Applicant | SIL-MED CORP. 700 WARNER BLVD. Taunton, MA 02780 |
| Contact | James D Mello |
| Correspondent | James D Mello SIL-MED CORP. 700 WARNER BLVD. Taunton, MA 02780 |
| Product Code | GBS |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-22 |
| Decision Date | 1986-08-07 |