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FDA 510(k)

DISPOSABLE PLASTIC VAGINAL SPECULUM

K-Number: K903080 · 1990-09-19

ApplicantDawnex Industries, Inc.
Decision Date1990-09-19
Product CodeHIB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE PLASTIC VAGINAL SPECULUM is the device name listed in this FDA 510(k) record. The listed applicant is Dawnex Industries, Inc.. It received FDA 510(k) clearance on 1990-09-19 under 510(k) number K903080. 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 DISPOSABLE PLASTIC VAGINAL SPECULUM?

DISPOSABLE PLASTIC VAGINAL SPECULUM is a medical device that received FDA 510(k) clearance on 1990-09-19. The listed applicant is Dawnex Industries, Inc.. The 510(k) number is K903080.

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

DISPOSABLE PLASTIC VAGINAL SPECULUM received FDA 510(k) clearance on 1990-09-19, under 510(k) number K903080.

Who is the listed applicant for DISPOSABLE PLASTIC VAGINAL SPECULUM?

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

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

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

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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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