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FDA 510(k)

MUCOTROL CONCENTRATED ORAL GEL WAFER

K-Number: K042400 · 2004-11-24

ApplicantBelcher Pharmaceuticals, Inc.
Decision Date2004-11-24
Product CodeOLR
DecisionSubstantially Equivalent

Device Summary

MUCOTROL CONCENTRATED ORAL GEL WAFER is the device name listed in this FDA 510(k) record. The listed applicant is Belcher Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 2004-11-24 under 510(k) number K042400. The device is classified under product code OLR. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MUCOTROL CONCENTRATED ORAL GEL WAFER?

MUCOTROL CONCENTRATED ORAL GEL WAFER is a medical device that received FDA 510(k) clearance on 2004-11-24. The listed applicant is Belcher Pharmaceuticals, Inc.. The 510(k) number is K042400.

When did MUCOTROL CONCENTRATED ORAL GEL WAFER receive FDA 510(k) clearance?

MUCOTROL CONCENTRATED ORAL GEL WAFER received FDA 510(k) clearance on 2004-11-24, under 510(k) number K042400.

Who is the listed applicant for MUCOTROL CONCENTRATED ORAL GEL WAFER?

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

What is the FDA product code for MUCOTROL CONCENTRATED ORAL GEL WAFER?

The FDA product code for MUCOTROL CONCENTRATED ORAL GEL WAFER is OLR.

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Related Devices (Code: OLR)

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.

K260120NaturaJel™ Oral Wound Care KitHCS Innovation, LLCK251908Emanate TrayEmanate BiomedicalK260126Curajel™ Oral GelUSpharma, Ltd.K253816MuCover (proposed name) Oral Wound DressingMoleculeX Co., Ltd.K253758Dental Cone; Dental SpongeMedizin Produkte Neustadt GmbH (Mpn)K252425Silatrix Oral GelSa3, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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