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FDA 510(k)

ALOE THERAPY ORAL RINSE

K-Number: K983182 · 1998-12-10

ApplicantCarrington Laboratories, Inc.
Decision Date1998-12-10
Product CodeOLR
DecisionSubstantially Equivalent

Device Summary

ALOE THERAPY ORAL RINSE 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 1998-12-10 under 510(k) number K983182. The device is classified under product code OLR. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALOE THERAPY ORAL RINSE?

ALOE THERAPY ORAL RINSE is a medical device that received FDA 510(k) clearance on 1998-12-10. The listed applicant is Carrington Laboratories, Inc.. The 510(k) number is K983182.

When did ALOE THERAPY ORAL RINSE receive FDA 510(k) clearance?

ALOE THERAPY ORAL RINSE received FDA 510(k) clearance on 1998-12-10, under 510(k) number K983182.

Who is the listed applicant for ALOE THERAPY ORAL RINSE?

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 ALOE THERAPY ORAL RINSE?

The FDA product code for ALOE THERAPY ORAL RINSE is OLR.

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Other records listing Carrington Laboratories, 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.

K022670CARRAKLENZ AND ULTRAKLENZK012126THE SALICEPT ORAL PATCHK964852RADIACARE ORAL WOUND RINSEK962218CARRASYN HYDROGEL WOUND DRESSING,CARRAGAUZE PADS,CARRAGAUZE STRIPS,CARRASORB M FDGK961758CARASYN HYDROGEL WOUND PRODUCTSK960428CARRASYN HYDROGEL WOUND DRESSING/FDG PADS/CARAGAUZE STRIPS/PADS (MODIFICATION)

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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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