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FDA 510(k)

GLO-SPEC I, II AND III

K-Number: K020959 · 2002-06-19

ApplicantSol Weiss MD, Inc.
Decision Date2002-06-19
Product CodeHIB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GLO-SPEC I, II AND III is the device name listed in this FDA 510(k) record. The listed applicant is Sol Weiss MD, Inc.. It received FDA 510(k) clearance on 2002-06-19 under 510(k) number K020959. 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 GLO-SPEC I, II AND III?

GLO-SPEC I, II AND III is a medical device that received FDA 510(k) clearance on 2002-06-19. The listed applicant is Sol Weiss MD, Inc.. The 510(k) number is K020959.

When did GLO-SPEC I, II AND III receive FDA 510(k) clearance?

GLO-SPEC I, II AND III received FDA 510(k) clearance on 2002-06-19, under 510(k) number K020959.

Who is the listed applicant for GLO-SPEC I, II AND III?

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

What is the FDA product code for GLO-SPEC I, II AND III?

The FDA product code for GLO-SPEC I, II AND III is HIB.

Other records listing Sol Weiss MD, Inc. 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.

K013817GLO-SPECK012859NU-SPEC D

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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