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K Number
K962273
Device Name
MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NST
Manufacturer
MARLO SURGICAL TECHNOLOGY
Date Cleared
1996-07-31

(48 days)

Product Code
MFD
Regulation Number
884.5250
Type
Traditional
Panel
OB
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 884.5250 Cervical cap.

(a)
Identification. A cervical cap is a flexible cuplike receptacle that fits over the cervix to collect menstrual flow or to aid artificial insemination. This generic type of device is not for contraceptive use.(b)
Classification. Class II (performance standards).