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FDA 510(k)

GENT-L-SPEC DISPOS. VAGINAL SPECULUM

K-Number: K830725 · 1983-04-27

ApplicantGeneva Laboratories, Inc.
Decision Date1983-04-27
Product CodeHIB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GENT-L-SPEC DISPOS. VAGINAL SPECULUM is the device name listed in this FDA 510(k) record. The listed applicant is Geneva Laboratories, Inc.. It received FDA 510(k) clearance on 1983-04-27 under 510(k) number K830725. 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 GENT-L-SPEC DISPOS. VAGINAL SPECULUM?

GENT-L-SPEC DISPOS. VAGINAL SPECULUM is a medical device that received FDA 510(k) clearance on 1983-04-27. The listed applicant is Geneva Laboratories, Inc.. The 510(k) number is K830725.

When did GENT-L-SPEC DISPOS. VAGINAL SPECULUM receive FDA 510(k) clearance?

GENT-L-SPEC DISPOS. VAGINAL SPECULUM received FDA 510(k) clearance on 1983-04-27, under 510(k) number K830725.

Who is the listed applicant for GENT-L-SPEC DISPOS. VAGINAL SPECULUM?

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

What is the FDA product code for GENT-L-SPEC DISPOS. VAGINAL SPECULUM?

The FDA product code for GENT-L-SPEC DISPOS. VAGINAL SPECULUM is HIB.

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Other records listing Geneva Laboratories, Inc. as applicant

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K881217GENT-L-KARE STERILE URINARY LEG BAGK881213GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTERK881218GENT-L-KARE CLEANSING ENEMA SETK881216GENT-L-KARE VAGINAL IRRIGATION SETK861308ACCUPAC CUSTOM PACK KERLIX SQUARESK861219ACCUPAC CUSTOM SKIN SCRUB KIT

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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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