Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NEW WEST SUNGLASSES

K-Number: K893986 · 1989-07-25

Decision Date1989-07-25
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

NEW WEST SUNGLASSES is the device name listed in this FDA 510(k) record. The listed applicant is New West Promotions. It received FDA 510(k) clearance on 1989-07-25 under 510(k) number K893986. The device is classified under product code HQY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEW WEST SUNGLASSES?

NEW WEST SUNGLASSES is a medical device that received FDA 510(k) clearance on 1989-07-25. The listed applicant is New West Promotions. The 510(k) number is K893986.

When did NEW WEST SUNGLASSES receive FDA 510(k) clearance?

NEW WEST SUNGLASSES received FDA 510(k) clearance on 1989-07-25, under 510(k) number K893986.

Who is the listed applicant for NEW WEST SUNGLASSES?

The FDA 510(k) record lists New West Promotions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEW WEST SUNGLASSES?

The FDA product code for NEW WEST SUNGLASSES is HQY.

Related Clinical Trials

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.

Related Devices (Code: HQY)

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.

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.

↑