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FDA 510(k)

THERMOMETER SHEATHS

K-Number: K813423 · 1981-12-18

ApplicantAbco Dealers, Inc.
Decision Date1981-12-18
Product CodeFLK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

THERMOMETER SHEATHS is the device name listed in this FDA 510(k) record. The listed applicant is Abco Dealers, Inc.. It received FDA 510(k) clearance on 1981-12-18 under 510(k) number K813423. The device is classified under product code FLK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMOMETER SHEATHS?

THERMOMETER SHEATHS is a medical device that received FDA 510(k) clearance on 1981-12-18. The listed applicant is Abco Dealers, Inc.. The 510(k) number is K813423.

When did THERMOMETER SHEATHS receive FDA 510(k) clearance?

THERMOMETER SHEATHS received FDA 510(k) clearance on 1981-12-18, under 510(k) number K813423.

Who is the listed applicant for THERMOMETER SHEATHS?

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

What is the FDA product code for THERMOMETER SHEATHS?

The FDA product code for THERMOMETER SHEATHS is FLK.

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Other records listing Abco Dealers, 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.

K905025DIGITAL THERMOMETER KITSK882304DIGITAL THERMOMETER SHEATHS (ORAL AND RECTAL)K880892BLOOD COLLECTING NEEDLE AND HOLDERSK880894ALLERGIST SYRINGESK872875STRETCH GAUZE BANDAGESK872874MICROSCOPE COVER GLASSES

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Related Devices (Code: FLK)

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.

K960185AMSINO CLINICAL THERMOMETERAmsia Intl., Inc.K960224GERATHERM MERCUIRY FREE CLINICAL THERMOMETERRg Ent., Inc.K953465KENTEMPKentron Health Care, Inc.K942483CLINICAL GLASS THERMOMETERMakol Medical Instruments Corp.K941673MEDIAID UNIVERSAL THERMOMETERPolymedica Industries, Inc.K940380AMG MED BRAND CLINICAL GLASS THERMOMETERAmg Medical, Inc.

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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