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FDA 510(k)

EYELID SPECULUM

K-Number: K830430 · 1983-06-10

ApplicantDouglas C. Mckee & Co.
Decision Date1983-06-10
Product CodeHNC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

EYELID SPECULUM is the device name listed in this FDA 510(k) record. The listed applicant is Douglas C. Mckee & Co.. It received FDA 510(k) clearance on 1983-06-10 under 510(k) number K830430. The device is classified under product code HNC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EYELID SPECULUM?

EYELID SPECULUM is a medical device that received FDA 510(k) clearance on 1983-06-10. The listed applicant is Douglas C. Mckee & Co.. The 510(k) number is K830430.

When did EYELID SPECULUM receive FDA 510(k) clearance?

EYELID SPECULUM received FDA 510(k) clearance on 1983-06-10, under 510(k) number K830430.

Who is the listed applicant for EYELID SPECULUM?

The FDA 510(k) record lists Douglas C. Mckee & Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EYELID SPECULUM?

The FDA product code for EYELID SPECULUM is HNC.

Related Clinical Trials

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Related Devices (Code: HNC)

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.

K022836STEPHENS DISPOSABLE SPECULUMStephens InstrumentsK981235OCULOSTATLaser Center Dev. Corp.K964289EYE FIXATION SPECULUMEyefix, Inc.K863989THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER)Keeler Instruments, Inc.K863664OPHTHALMIC SURGICAL SPECULUMMyocure, Inc.K843196VISITEC EYE SPECULUMVisitec Co.

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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