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FDA 510(k)

DISPOSABLE FACE MASK

K-Number: K904719 · 1991-01-02

ApplicantTri/Bor Medical, Inc.
Decision Date1991-01-02
Product CodeBYG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE FACE MASK is the device name listed in this FDA 510(k) record. The listed applicant is Tri/Bor Medical, Inc.. It received FDA 510(k) clearance on 1991-01-02 under 510(k) number K904719. The device is classified under product code BYG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE FACE MASK?

DISPOSABLE FACE MASK is a medical device that received FDA 510(k) clearance on 1991-01-02. The listed applicant is Tri/Bor Medical, Inc.. The 510(k) number is K904719.

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

DISPOSABLE FACE MASK received FDA 510(k) clearance on 1991-01-02, under 510(k) number K904719.

Who is the listed applicant for DISPOSABLE FACE MASK?

The FDA 510(k) record lists Tri/Bor Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE FACE MASK?

The FDA product code for DISPOSABLE FACE MASK is BYG.

Related Clinical Trials

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.

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Other records listing Tri/Bor Medical, 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.

K904718AERO-GEN NUBULIZER SYSTEMK904717MICRO-VENT NEBULIZER SYSTEMK904716AERO-GEN NEBULIZERK904715OXYGEN/AIR TUBING

Related Devices (Code: BYG)

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.

K963298FIRST AID KIT(S)Vector, Inc.K962848HANS RUDOLPH NASAL CPAP MASKHans Rudolph, Inc.K945482DISPOSABLE, CPAP OXYGEN MASKFvtnksK953464WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASKWestmed, Inc.K953039VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKSDadsun Corp., Ltd.K945472WESTMED PEDIATRIC AND ADULT AEROSOL MASKWestmed Intl.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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