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FDA 510(k)

DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER

K-Number: K962290 · 1996-07-03

ApplicantDebusk Technology Corp.
Decision Date1996-07-03
Product CodeFOK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER is the device name listed in this FDA 510(k) record. The listed applicant is Debusk Technology Corp.. It received FDA 510(k) clearance on 1996-07-03 under 510(k) number K962290. The device is classified under product code FOK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER?

DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER is a medical device that received FDA 510(k) clearance on 1996-07-03. The listed applicant is Debusk Technology Corp.. The 510(k) number is K962290.

When did DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER receive FDA 510(k) clearance?

DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER received FDA 510(k) clearance on 1996-07-03, under 510(k) number K962290.

Who is the listed applicant for DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER?

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

What is the FDA product code for DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER?

The FDA product code for DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER is FOK.

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Other records listing Debusk Technology Corp. as applicant

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Related Devices (Code: FOK)

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K926118LIFE TRACE(R) BILIRUBIN MASKGraphic Controls Corp.K851918INFANT PHOTOTHERAPY MASKAlba Health CareK840894PHOTO-THERAPY EYE PROTECTORA & A Medical Supplies Co.K813214INFANT PHOTOTHERAPY MASKMontrose Phototherapy Supply

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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