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FDA 510(k)

GONGDONG DISPOSABLE VAGINAL SPECULUM

K-Number: K050887 · 2005-07-11

ApplicantZhejiang Gongdong Medical Plastic Factory
Decision Date2005-07-11
Product CodeHIB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GONGDONG DISPOSABLE VAGINAL SPECULUM is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Gongdong Medical Plastic Factory. It received FDA 510(k) clearance on 2005-07-11 under 510(k) number K050887. 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 GONGDONG DISPOSABLE VAGINAL SPECULUM?

GONGDONG DISPOSABLE VAGINAL SPECULUM is a medical device that received FDA 510(k) clearance on 2005-07-11. The listed applicant is Zhejiang Gongdong Medical Plastic Factory. The 510(k) number is K050887.

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

GONGDONG DISPOSABLE VAGINAL SPECULUM received FDA 510(k) clearance on 2005-07-11, under 510(k) number K050887.

Who is the listed applicant for GONGDONG DISPOSABLE VAGINAL SPECULUM?

The FDA 510(k) record lists Zhejiang Gongdong Medical Plastic Factory as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

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Other records listing Zhejiang Gongdong Medical Plastic Factory 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.

K082042GONGDONG DISPOSABLE SHARP CONTAINER

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

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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