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FDA 510(k)

RADIACARE ORAL WOUND RINSE

K-Number: K964852 · 1997-03-03

ApplicantCarrington Laboratories, Inc.
Decision Date1997-03-03
Product CodeOLR
DecisionSubstantially Equivalent

Device Summary

RADIACARE ORAL WOUND 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 1997-03-03 under 510(k) number K964852. The device is classified under product code OLR. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIACARE ORAL WOUND RINSE?

RADIACARE ORAL WOUND RINSE is a medical device that received FDA 510(k) clearance on 1997-03-03. The listed applicant is Carrington Laboratories, Inc.. The 510(k) number is K964852.

When did RADIACARE ORAL WOUND RINSE receive FDA 510(k) clearance?

RADIACARE ORAL WOUND RINSE received FDA 510(k) clearance on 1997-03-03, under 510(k) number K964852.

Who is the listed applicant for RADIACARE ORAL WOUND 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 RADIACARE ORAL WOUND RINSE?

The FDA product code for RADIACARE ORAL WOUND 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 PATCHK983182ALOE THERAPY ORAL 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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