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FDA 510(k)

DISPOSABLE APRON

K-Number: K964364 · 1997-02-25

ApplicantInstrument Makar, Inc.
Decision Date1997-02-25
Product CodeLYU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE APRON 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 1997-02-25 under 510(k) number K964364. 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 DISPOSABLE APRON?

DISPOSABLE APRON is a medical device that received FDA 510(k) clearance on 1997-02-25. The listed applicant is Instrument Makar, Inc.. The 510(k) number is K964364.

When did DISPOSABLE APRON receive FDA 510(k) clearance?

DISPOSABLE APRON received FDA 510(k) clearance on 1997-02-25, under 510(k) number K964364.

Who is the listed applicant for DISPOSABLE APRON?

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 DISPOSABLE APRON?

The FDA product code for DISPOSABLE APRON 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 ANCHORK955835FLUID BARRIER BOOT KNEE & ANKLE-HIGHK960555BIOASBSORBABLE MINI-SCREW SUTURE ANCHORK943249BIOABSORBABLE INTERFERENCE SCREW

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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.K961791DEPUY DISPOSABLE FILTER/HOODDepuy, Inc.K961454AMMI MAGNI-GUARDAmerican Medical Mfg., Inc.K945302SLOAN STA-DRI PANT PROTECTORSloan Corp.

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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