MMODIFICATION TO LAMINARIA
Device Facts
| Record ID | K011512 |
|---|---|
| Device Name | MMODIFICATION TO LAMINARIA |
| Applicant | A & A Medical, Inc. |
| Product Code | HDY · Obstetrics/Gynecology |
| Decision Date | Jul 9, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.4260 |
| Device Class | Class 2 |
Regulatory Classification
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.
