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FDA 510(k)

MAKAR FULL AND HALF FACE SHIELD

K-Number: K942828 · 1995-02-23

ApplicantInstrument Makar, Inc.
Decision Date1995-02-23
Product CodeLYU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MAKAR FULL AND HALF FACE SHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Instrument Makar, Inc.. It received FDA 510(k) clearance on 1995-02-23 under 510(k) number K942828. 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 MAKAR FULL AND HALF FACE SHIELD?

MAKAR FULL AND HALF FACE SHIELD is a medical device that received FDA 510(k) clearance on 1995-02-23. The listed applicant is Instrument Makar, Inc.. The 510(k) number is K942828.

When did MAKAR FULL AND HALF FACE SHIELD receive FDA 510(k) clearance?

MAKAR FULL AND HALF FACE SHIELD received FDA 510(k) clearance on 1995-02-23, under 510(k) number K942828.

Who is the listed applicant for MAKAR FULL AND HALF FACE SHIELD?

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

What is the FDA product code for MAKAR FULL AND HALF FACE SHIELD?

The FDA product code for MAKAR FULL AND HALF FACE SHIELD is LYU.

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Other records listing Instrument Makar, 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.

K002600LITWIN CRUICATE ANCHORK980999ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANTK963396BIOSPHERE SUTURE ANCHORK964364DISPOSABLE APRONK955835FLUID BARRIER BOOT KNEE & ANKLE-HIGHK960555BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR

View all 28 devices →

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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