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FDA 510(k)

INTEC FULL FACE SHIELD

K-Number: K946003 · 1995-06-28

ApplicantIntec Industries, Inc.
Decision Date1995-06-28
Product CodeLYU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INTEC FULL FACE SHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Intec Industries, Inc.. It received FDA 510(k) clearance on 1995-06-28 under 510(k) number K946003. 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 INTEC FULL FACE SHIELD?

INTEC FULL FACE SHIELD is a medical device that received FDA 510(k) clearance on 1995-06-28. The listed applicant is Intec Industries, Inc.. The 510(k) number is K946003.

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

INTEC FULL FACE SHIELD received FDA 510(k) clearance on 1995-06-28, under 510(k) number K946003.

Who is the listed applicant for INTEC FULL FACE SHIELD?

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

What is the FDA product code for INTEC FULL FACE SHIELD?

The FDA product code for INTEC FULL 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.

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Other records listing Intec Industries, 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.

K946343INTEC EXTENDED EYE SHIELD WITH MASK

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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