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FDA 510(k)

MULTIPLE-LENS, SPECTACLES, CUSTOM

K-Number: K842188 · 1984-12-11

ApplicantGold Cadillac Co.
Decision Date1984-12-11
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MULTIPLE-LENS, SPECTACLES, CUSTOM is the device name listed in this FDA 510(k) record. The listed applicant is Gold Cadillac Co.. It received FDA 510(k) clearance on 1984-12-11 under 510(k) number K842188. The device is classified under product code HQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULTIPLE-LENS, SPECTACLES, CUSTOM?

MULTIPLE-LENS, SPECTACLES, CUSTOM is a medical device that received FDA 510(k) clearance on 1984-12-11. The listed applicant is Gold Cadillac Co.. The 510(k) number is K842188.

When did MULTIPLE-LENS, SPECTACLES, CUSTOM receive FDA 510(k) clearance?

MULTIPLE-LENS, SPECTACLES, CUSTOM received FDA 510(k) clearance on 1984-12-11, under 510(k) number K842188.

Who is the listed applicant for MULTIPLE-LENS, SPECTACLES, CUSTOM?

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

What is the FDA product code for MULTIPLE-LENS, SPECTACLES, CUSTOM?

The FDA product code for MULTIPLE-LENS, SPECTACLES, CUSTOM is HQE.

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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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