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FDA 510(k)

MODEL 0450000, OPAL MEDICAL EXAM LIGHT

K-Number: K893808 · 1989-08-15

ApplicantBurton Medical Products Corp.
Decision Date1989-08-15
Product CodeKZF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODEL 0450000, OPAL MEDICAL EXAM LIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Burton Medical Products Corp.. It received FDA 510(k) clearance on 1989-08-15 under 510(k) number K893808. The device is classified under product code KZF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 0450000, OPAL MEDICAL EXAM LIGHT?

MODEL 0450000, OPAL MEDICAL EXAM LIGHT is a medical device that received FDA 510(k) clearance on 1989-08-15. The listed applicant is Burton Medical Products Corp.. The 510(k) number is K893808.

When did MODEL 0450000, OPAL MEDICAL EXAM LIGHT receive FDA 510(k) clearance?

MODEL 0450000, OPAL MEDICAL EXAM LIGHT received FDA 510(k) clearance on 1989-08-15, under 510(k) number K893808.

Who is the listed applicant for MODEL 0450000, OPAL MEDICAL EXAM LIGHT?

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

What is the FDA product code for MODEL 0450000, OPAL MEDICAL EXAM LIGHT?

The FDA product code for MODEL 0450000, OPAL MEDICAL EXAM LIGHT is KZF.

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Other records listing Burton Medical Products Corp. 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.

K101537AIM 200, MAJOR SURGICAL LIGHTK042395OUTPATIENT III MINOR SURGERY LIGHTK000639VISIONARY 2000K963682GENIE' SINGLE CEILING AND DOUBLE CEILINGK961843GENIEK935102SATURN LIGHT

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Related Devices (Code: KZF)

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.

K954943NEVOSCOPENizar A. MullaniK952835WELCH ALLYN VIDEO EPISCOPEWelch Allyn, Inc.K945507H 5100, H 5200, H 5300Rudolf Riester GmbH & Co. KGK941869SPLINT, PNEUMATIC, ARM & SPLINT, PNEUMATIC, LEGThe Lighthouse For the Blind, Inc.K936088WAVE FLUORESCENT MAGNIFIERBurton Medical Products Corp.K940284MEDDEV MULTARRAY MEDICAL EXAMINING LIGHT MODIFICATIONMeddev International 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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