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FDA 510(k)

OCUSHIELDS MASKS

K-Number: K884877 · 1989-01-10

ApplicantDioptics
Decision Date1989-01-10
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OCUSHIELDS MASKS is the device name listed in this FDA 510(k) record. The listed applicant is Dioptics. It received FDA 510(k) clearance on 1989-01-10 under 510(k) number K884877. 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 OCUSHIELDS MASKS?

OCUSHIELDS MASKS is a medical device that received FDA 510(k) clearance on 1989-01-10. The listed applicant is Dioptics. The 510(k) number is K884877.

When did OCUSHIELDS MASKS receive FDA 510(k) clearance?

OCUSHIELDS MASKS received FDA 510(k) clearance on 1989-01-10, under 510(k) number K884877.

Who is the listed applicant for OCUSHIELDS MASKS?

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

What is the FDA product code for OCUSHIELDS MASKS?

The FDA product code for OCUSHIELDS MASKS 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 Dioptics 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.

K903487SOLARSHIELDS ENCOREK884878SOLARETTESK885163DIOPTICS EYESHIELDSK884929OCCUSHIELDSK862719SOLARSHIELDS

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

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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