K903989 is an FDA 510(k) clearance for the SIL-MED T-TUBE DRAIN. This device is classified as a Drain, Cervical (Class II - Special Controls, product code HFL).
Submitted by Sil-Med Corp. (Taunton, US). The FDA issued a Cleared decision on January 31, 1991, 155 days after receiving the submission on August 29, 1990.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.3200.
| 510(k) Number | K903989 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 1990 |
| Decision Date | January 31, 1991 |
| Days to Decision | 155 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HFL — Drain, Cervical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.3200 |