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FDA 510(k)

ARCTIC PREMIER SERIES

K-Number: K944700 · 1994-12-22

ApplicantSungold Eyewear, Inc.
Decision Date1994-12-22
Product CodeHOY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ARCTIC PREMIER SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Sungold Eyewear, Inc.. It received FDA 510(k) clearance on 1994-12-22 under 510(k) number K944700. The device is classified under product code HOY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARCTIC PREMIER SERIES?

ARCTIC PREMIER SERIES is a medical device that received FDA 510(k) clearance on 1994-12-22. The listed applicant is Sungold Eyewear, Inc.. The 510(k) number is K944700.

When did ARCTIC PREMIER SERIES receive FDA 510(k) clearance?

ARCTIC PREMIER SERIES received FDA 510(k) clearance on 1994-12-22, under 510(k) number K944700.

Who is the listed applicant for ARCTIC PREMIER SERIES?

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

What is the FDA product code for ARCTIC PREMIER SERIES?

The FDA product code for ARCTIC PREMIER SERIES is HOY.

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Related Devices (Code: HOY)

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.

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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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