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FDA 510(k)

ANESTHESIA FACE MASK

K-Number: K953295 · 1995-08-11

ApplicantMallinckrodt Medical
Decision Date1995-08-11
Product CodeBSJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ANESTHESIA FACE MASK is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Medical. It received FDA 510(k) clearance on 1995-08-11 under 510(k) number K953295. The device is classified under product code BSJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANESTHESIA FACE MASK?

ANESTHESIA FACE MASK is a medical device that received FDA 510(k) clearance on 1995-08-11. The listed applicant is Mallinckrodt Medical. The 510(k) number is K953295.

When did ANESTHESIA FACE MASK receive FDA 510(k) clearance?

ANESTHESIA FACE MASK received FDA 510(k) clearance on 1995-08-11, under 510(k) number K953295.

Who is the listed applicant for ANESTHESIA FACE MASK?

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 ANESTHESIA FACE MASK?

The FDA product code for ANESTHESIA FACE MASK is BSJ.

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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: BSJ)

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.

K163277SuperNO2VA DeviceRevolutionary Medical Devices, Inc.K953107ANESTHESIA/RESPIRATORY FACE MASKMedical Marketing ConceptsK952689BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASKOwens-Brigam Medical Co.K951043AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASKPromedic, Inc.K950771DISPOSABLE ADHESIVE FACE MASKAdvanced Warming Systems, Inc.K945894MASK, GAS, ANESTHETICHans Rudolph, 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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