← Product Code [HFL](/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/HFL) · K903989

# SIL-MED T-TUBE DRAIN (K903989)

_Sil-Med Corp. · HFL · Jan 31, 1991 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/HFL/K903989

## Device Facts

- **Applicant:** Sil-Med Corp.
- **Product Code:** [HFL](/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/HFL.md)
- **Decision Date:** Jan 31, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.3200
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/HFL/K903989](https://fda.innolitics.com/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/HFL/K903989)

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