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K Number
K011512

Validate with FDA (Live)

Device Name
MMODIFICATION TO LAMINARIA
Manufacturer
A & A MEDICAL, INC.
Date Cleared
2001-07-09

(54 days)

Product Code
HDY
Regulation Number
884.4260
Type
Traditional
Panel
Obstetrics/Gynecology
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 884.4260 Hygroscopic Laminaria cervical dilator.

(a)
Identification. A hygroscopicLaminaria 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 orLaminaria japonica). The device is used to induce abortion.(b)
Classification. Class II (performance standards).