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FDA 510(k)

KOLPLAST VAGINAL SPECULUM

K-Number: K973853 · 1997-12-19

ApplicantKolplast Comercial E Industrial Ltda
Decision Date1997-12-19
Product CodeHIB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

KOLPLAST VAGINAL SPECULUM is the device name listed in this FDA 510(k) record. The listed applicant is Kolplast Comercial E Industrial Ltda. It received FDA 510(k) clearance on 1997-12-19 under 510(k) number K973853. 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 KOLPLAST VAGINAL SPECULUM?

KOLPLAST VAGINAL SPECULUM is a medical device that received FDA 510(k) clearance on 1997-12-19. The listed applicant is Kolplast Comercial E Industrial Ltda. The 510(k) number is K973853.

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

KOLPLAST VAGINAL SPECULUM received FDA 510(k) clearance on 1997-12-19, under 510(k) number K973853.

Who is the listed applicant for KOLPLAST VAGINAL SPECULUM?

The FDA 510(k) record lists Kolplast Comercial E Industrial Ltda as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KOLPLAST VAGINAL SPECULUM?

The FDA product code for KOLPLAST 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

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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