LogoFDA 510(k) Search
K Number
K965064
Device Name
ROSTAM APPLICATOR TAMPON/ROSTAM NON APPLICATOR TAMPON
Manufacturer
ROSTAM LTD.
Date Cleared
1997-02-20

(64 days)

Product Code
HEB
Regulation Number
884.5470
Type
Traditional
Panel
OB
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 884.5470 Unscented menstrual tampon.

(a)
Identification. An unscented menstrual tampon is a device that is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge. This generic type of device does not include menstrual tampons treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.(b)
Classification. Class II (performance standards).