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K Number
K003380
Device Name
BIOTEQUE VAGINAL DILATOR
Manufacturer
BIOTEQUE AMERICA, INC.
Date Cleared
2001-01-29

(90 days)

Product Code
HDX
Regulation Number
884.3900
Type
Traditional
Panel
OB
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 884.3900 Vaginal stent.

(a)
Identification. A vaginal stent is a device used to enlarge the vagina by stretching, or to support the vagina and to hold a skin graft after reconstructive surgery.(b)
Classification. Class II (performance standards).