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FDA 510(k)

MEDISUL DISPOSABLE VAGINAL SPECULUM

K-Number: K000414 · 2000-04-04

ApplicantMarketing Perspectives
Decision Date2000-04-04
Product CodeHIB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MEDISUL DISPOSABLE VAGINAL SPECULUM is the device name listed in this FDA 510(k) record. The listed applicant is Marketing Perspectives. It received FDA 510(k) clearance on 2000-04-04 under 510(k) number K000414. The device is classified under product code HIB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDISUL DISPOSABLE VAGINAL SPECULUM?

MEDISUL DISPOSABLE VAGINAL SPECULUM is a medical device that received FDA 510(k) clearance on 2000-04-04. The listed applicant is Marketing Perspectives. The 510(k) number is K000414.

When did MEDISUL DISPOSABLE VAGINAL SPECULUM receive FDA 510(k) clearance?

MEDISUL DISPOSABLE VAGINAL SPECULUM received FDA 510(k) clearance on 2000-04-04, under 510(k) number K000414.

Who is the listed applicant for MEDISUL DISPOSABLE VAGINAL SPECULUM?

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

What is the FDA product code for MEDISUL DISPOSABLE VAGINAL SPECULUM?

The FDA product code for MEDISUL DISPOSABLE VAGINAL SPECULUM is HIB.

Related Clinical Trials

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Other records listing Marketing Perspectives 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.

K953669PERSPECTIVES IMPREGNATED HYDROGEL WOUND DRESSING

Related Devices (Code: HIB)

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.

K252208JFord Speculum Sleeve™Ford Medtech, LLCK130046CLEARSPEC SINGLE USE VAGINAL SPECULUMClearspec, LLCK120743SPECULUM, VAGINAL, NONMETALWelch Allyn, Inc.K110766KOLPLUX SYSTEMKolplast CI LtdaK092870NON-STERILE DISPOSABLE VAGINAL SPECULUMKunshan Deyi Plastic Co., Ltd.K091937OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUMObp Corporation

Official Source

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

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