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FDA 510(k)

UTK-DTE AUTILARY SHIELD

K-Number: K954146 · 1995-12-06

ApplicantMallinckrodt Medical
Decision Date1995-12-06
Product CodeKPY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

UTK-DTE AUTILARY SHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Medical. It received FDA 510(k) clearance on 1995-12-06 under 510(k) number K954146. The device is classified under product code KPY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UTK-DTE AUTILARY SHIELD?

UTK-DTE AUTILARY SHIELD is a medical device that received FDA 510(k) clearance on 1995-12-06. The listed applicant is Mallinckrodt Medical. The 510(k) number is K954146.

When did UTK-DTE AUTILARY SHIELD receive FDA 510(k) clearance?

UTK-DTE AUTILARY SHIELD received FDA 510(k) clearance on 1995-12-06, under 510(k) number K954146.

Who is the listed applicant for UTK-DTE AUTILARY SHIELD?

The FDA 510(k) record lists Mallinckrodt Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UTK-DTE AUTILARY SHIELD?

The FDA product code for UTK-DTE AUTILARY SHIELD is KPY.

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Other records listing Mallinckrodt Medical 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.

K082520SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBESK051416SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULAK972258HI-CARE CLOSED SUCTION SYSTEMK971267SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EXTENSION, CUFFED, PROXIMAL EXTENSION, CUFK963732PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULAK955721CUFFED OROPHARYNGEAL AIRWAY (COPA)

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Related Devices (Code: KPY)

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.

K110900DISPOSABLE THYROID COLLARBloxr CorporationK962622INTRA-ORAL THERMOPLASTIC SHIELDMedtec, Inc.K954456THERMOPLASTIC SHIELDMedtec, Inc.K953610AUKULYTEAukland Medical Plastics, Inc.K9510042001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4)Kenex , Ltd.K951003KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5)Kenex , Ltd.

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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