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FDA 510(k)

DI-CROWN

K-Number: K812441 · 1981-10-06

ApplicantCoburn Optical Ind., Inc.
Decision Date1981-10-06
Product CodeHQG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DI-CROWN is the device name listed in this FDA 510(k) record. The listed applicant is Coburn Optical Ind., Inc.. It received FDA 510(k) clearance on 1981-10-06 under 510(k) number K812441. The device is classified under product code HQG. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DI-CROWN?

DI-CROWN is a medical device that received FDA 510(k) clearance on 1981-10-06. The listed applicant is Coburn Optical Ind., Inc.. The 510(k) number is K812441.

When did DI-CROWN receive FDA 510(k) clearance?

DI-CROWN received FDA 510(k) clearance on 1981-10-06, under 510(k) number K812441.

Who is the listed applicant for DI-CROWN?

The FDA 510(k) record lists Coburn Optical Ind., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DI-CROWN?

The FDA product code for DI-CROWN is HQG.

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Other records listing Coburn Optical Ind., Inc. as applicant

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Related Devices (Code: HQG)

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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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