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FDA 510(k)

MONOGARD FACE SHIELD

K-Number: K943809 · 1994-11-28

ApplicantWhite Knight Healthcare
Decision Date1994-11-28
Product CodeLYU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MONOGARD FACE SHIELD is the device name listed in this FDA 510(k) record. The listed applicant is White Knight Healthcare. It received FDA 510(k) clearance on 1994-11-28 under 510(k) number K943809. The device is classified under product code LYU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONOGARD FACE SHIELD?

MONOGARD FACE SHIELD is a medical device that received FDA 510(k) clearance on 1994-11-28. The listed applicant is White Knight Healthcare. The 510(k) number is K943809.

When did MONOGARD FACE SHIELD receive FDA 510(k) clearance?

MONOGARD FACE SHIELD received FDA 510(k) clearance on 1994-11-28, under 510(k) number K943809.

Who is the listed applicant for MONOGARD FACE SHIELD?

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

What is the FDA product code for MONOGARD FACE SHIELD?

The FDA product code for MONOGARD FACE SHIELD is LYU.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing White Knight Healthcare 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.

K951984WHITE KNIGHT SURGEON'S VESTK942577SURGICAL TIP CLEANERK942576CLEAR LENS ENDOSCOPIC FOG REDUCTION DEVICEK934969DUALGARD FACE SHIELD

Related Devices (Code: LYU)

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.

K011755STRYKER T4 HYTREL (R) TOGASStryker Corp.K965237NURSES BOUFFANT CAPCopioumed Intl., Inc.K970988FAR-EAST BOUFFANT CAPSFar East Science & Technology Development Co., Ltd.K964364DISPOSABLE APRONInstrument Makar, Inc.K961791DEPUY DISPOSABLE FILTER/HOODDepuy, Inc.K961454AMMI MAGNI-GUARDAmerican Medical Mfg., 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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