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FDA 510(k)

INTEC EXTENDED EYE SHIELD WITH MASK

K-Number: K946343 · 1995-03-22

ApplicantIntec Industries, Inc.
Decision Date1995-03-22
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INTEC EXTENDED EYE SHIELD WITH MASK 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 1995-03-22 under 510(k) number K946343. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTEC EXTENDED EYE SHIELD WITH MASK?

INTEC EXTENDED EYE SHIELD WITH MASK is a medical device that received FDA 510(k) clearance on 1995-03-22. The listed applicant is Intec Industries, Inc.. The 510(k) number is K946343.

When did INTEC EXTENDED EYE SHIELD WITH MASK receive FDA 510(k) clearance?

INTEC EXTENDED EYE SHIELD WITH MASK received FDA 510(k) clearance on 1995-03-22, under 510(k) number K946343.

Who is the listed applicant for INTEC EXTENDED EYE SHIELD WITH MASK?

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 EXTENDED EYE SHIELD WITH MASK?

The FDA product code for INTEC EXTENDED EYE SHIELD WITH MASK is FXX.

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.

K946003INTEC FULL FACE SHIELD

Related Devices (Code: FXX)

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.

K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround VisorO&M Halyard, Inc.K252534Surgical Face Mask (Ear mount)Zhejiang Hangkang Medical Equipment Co., Ltd.K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc.K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.K252650Disposable Medical Face MaskMakrite Industries, Inc.K243342KP Protective Face MaskKp Trading Co., Ltd.

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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