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FDA 510(k)

ROSTAM APPLICATOR TAMPON/ROSTAM NON APPLICATOR TAMPON

K-Number: K965064 · 1997-02-20

ApplicantRostam , Ltd.
Decision Date1997-02-20
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ROSTAM APPLICATOR TAMPON/ROSTAM NON APPLICATOR TAMPON is the device name listed in this FDA 510(k) record. The listed applicant is Rostam , Ltd.. It received FDA 510(k) clearance on 1997-02-20 under 510(k) number K965064. The device is classified under product code HEB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROSTAM APPLICATOR TAMPON/ROSTAM NON APPLICATOR TAMPON?

ROSTAM APPLICATOR TAMPON/ROSTAM NON APPLICATOR TAMPON is a medical device that received FDA 510(k) clearance on 1997-02-20. The listed applicant is Rostam , Ltd.. The 510(k) number is K965064.

When did ROSTAM APPLICATOR TAMPON/ROSTAM NON APPLICATOR TAMPON receive FDA 510(k) clearance?

ROSTAM APPLICATOR TAMPON/ROSTAM NON APPLICATOR TAMPON received FDA 510(k) clearance on 1997-02-20, under 510(k) number K965064.

Who is the listed applicant for ROSTAM APPLICATOR TAMPON/ROSTAM NON APPLICATOR TAMPON?

The FDA 510(k) record lists Rostam , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROSTAM APPLICATOR TAMPON/ROSTAM NON APPLICATOR TAMPON?

The FDA product code for ROSTAM APPLICATOR TAMPON/ROSTAM NON APPLICATOR TAMPON is HEB.

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Other records listing Rostam , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K102445ROSTAM SCENTED AND UNSCENTED BIODEGRADABLE PLASTIC APPLICATOR TAMPONSK090071ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED NEW PLASTIC APPLICATOR TAMPONSK062001ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONSK042773ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONSK030474PH BUFFERING PLASTIC APPLICATOR TAMPONK032080ROSTAM LTD FRAGRANCED PLASTIC APPLICATOR TAMPONS

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Related Devices (Code: HEB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252005Livi DeviceLiviwell, Inc.K253719Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital TamponsUnibeauty (Hubei) Technology Co., Ltd.K252939COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONSCotton High Tech S.L.K252613Unscented menstrual three-piece applicator tamponUnibeauty (Hubei) Technology Co., Ltd.K251033Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital TamponsUnibeauty (Hubei) Technology Co., Ltd.K242105SABA TamponsEssity Higiene Y Salud Mexico. S.A. DE C.V.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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