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K Number
K002329
Device Name
PELVX GELLHORN VAGINAL PESSARY 603-608
Manufacturer
DESCHUTES MEDICAL PRODUCTS, INC.
Date Cleared
2000-09-18

(48 days)

Product Code
HHW
Regulation Number
884.3575
Type
Traditional
Panel
Obstetrics/Gynecology
Reference & Predicate Devices
N/A
Predicate For
K012277
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 884.3575 Vaginal pessary.

(a)
Identification. A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia.(b)
Classification. Class II (performance standards).