SIL-MED T-TUBE DRAIN
Device Facts
| Record ID | K903989 |
|---|---|
| Device Name | SIL-MED T-TUBE DRAIN |
| Applicant | Sil-Med Corp. |
| Product Code | HFL · Obstetrics/Gynecology |
| Decision Date | Jan 31, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.3200 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A cervical drain is a device designed to provide an exit channel for draining discharge from the cervix after pelvic surgery.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
