← Product Code [HDY](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDY) · K782067

# DILATOR, MIZUTANI LAMINARIA TENT (K782067)

_British Marketing Ent., Ltd. · HDY · Jan 3, 1979 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDY/K782067

## Device Facts

- **Applicant:** British Marketing Ent., Ltd.
- **Product Code:** [HDY](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDY.md)
- **Decision Date:** Jan 3, 1979
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.4260
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## Regulatory Identification

A hygroscopic Laminaria cervical dilator is a device designed to dilate (stretch open) the cervical os by cervical insertion of a conical and expansible material made from the root of a seaweed (Laminaria digitata or Laminaria japonica). The device is used to induce abortion.

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDY/K782067](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDY/K782067)

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