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)

SUNGLASSES AND SUNGLASS FRAMES VARIOUS COLORS

K-Number: K870178 · 1987-04-16

ApplicantPolinelli
Decision Date1987-04-16
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SUNGLASSES AND SUNGLASS FRAMES VARIOUS COLORS is the device name listed in this FDA 510(k) record. The listed applicant is Polinelli. It received FDA 510(k) clearance on 1987-04-16 under 510(k) number K870178. 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 SUNGLASSES AND SUNGLASS FRAMES VARIOUS COLORS?

SUNGLASSES AND SUNGLASS FRAMES VARIOUS COLORS is a medical device that received FDA 510(k) clearance on 1987-04-16. The listed applicant is Polinelli. The 510(k) number is K870178.

When did SUNGLASSES AND SUNGLASS FRAMES VARIOUS COLORS receive FDA 510(k) clearance?

SUNGLASSES AND SUNGLASS FRAMES VARIOUS COLORS received FDA 510(k) clearance on 1987-04-16, under 510(k) number K870178.

Who is the listed applicant for SUNGLASSES AND SUNGLASS FRAMES VARIOUS COLORS?

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

What is the FDA product code for SUNGLASSES AND SUNGLASS FRAMES VARIOUS COLORS?

The FDA product code for SUNGLASSES AND SUNGLASS FRAMES VARIOUS COLORS 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.

Other records listing Polinelli as applicant

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.

↑