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FDA 510(k)

DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE

K-Number: K020726 · 2002-05-15

ApplicantDukal Corp.
Decision Date2002-05-15
Product CodeHIB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE is the device name listed in this FDA 510(k) record. The listed applicant is Dukal Corp.. It received FDA 510(k) clearance on 2002-05-15 under 510(k) number K020726. 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 DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE?

DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE is a medical device that received FDA 510(k) clearance on 2002-05-15. The listed applicant is Dukal Corp.. The 510(k) number is K020726.

When did DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE receive FDA 510(k) clearance?

DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE received FDA 510(k) clearance on 2002-05-15, under 510(k) number K020726.

Who is the listed applicant for DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE?

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

What is the FDA product code for DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE?

The FDA product code for DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE is HIB.

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Other records listing Dukal Corp. 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.

K083320DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPEK070407DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE; ANTI FOG TIE, LOOP, SHIELD, YELLOW, WHITE, AND BLUEK061864DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560K984564ETHYL CHLORIDE DISPENSERK970457DUKAL ABD COMBINE PADK970455DUKAL NON ADHERENT DRESSING

View all 11 devices →

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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