The following data is part of a premarket notification filed by Sil-med Corp. with the FDA for Sil-med Flat Suction Drain.
| Device ID | K921424 |
| 510k Number | K921424 |
| Device Name: | SIL-MED FLAT SUCTION DRAIN |
| Classification | Catheter, Irrigation |
| Applicant | SIL-MED CORP. 700 WARNER BLVD. Taunton, MA 02780 |
| Contact | Lourdes V Concepcio |
| Correspondent | Lourdes V Concepcio 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 | 1992-03-24 |
| Decision Date | 1992-09-28 |