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FDA 510(k)

THE SALICEPT ORAL PATCH

K-Number: K012126 · 2001-10-03

ApplicantCarrington Laboratories, Inc.
Decision Date2001-10-03
Product CodeOLR
DecisionSubstantially Equivalent

Device Summary

THE SALICEPT ORAL PATCH is the device name listed in this FDA 510(k) record. The listed applicant is Carrington Laboratories, Inc.. It received FDA 510(k) clearance on 2001-10-03 under 510(k) number K012126. The device is classified under product code OLR. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE SALICEPT ORAL PATCH?

THE SALICEPT ORAL PATCH is a medical device that received FDA 510(k) clearance on 2001-10-03. The listed applicant is Carrington Laboratories, Inc.. The 510(k) number is K012126.

When did THE SALICEPT ORAL PATCH receive FDA 510(k) clearance?

THE SALICEPT ORAL PATCH received FDA 510(k) clearance on 2001-10-03, under 510(k) number K012126.

Who is the listed applicant for THE SALICEPT ORAL PATCH?

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

What is the FDA product code for THE SALICEPT ORAL PATCH?

The FDA product code for THE SALICEPT ORAL PATCH is OLR.

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Other records listing Carrington Laboratories, Inc. as applicant

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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

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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