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FDA 510(k)

UNIKA

K-Number: K971327 · 1997-05-09

ApplicantEyewear Partners Co.
Decision Date1997-05-09
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

UNIKA is the device name listed in this FDA 510(k) record. The listed applicant is Eyewear Partners Co.. It received FDA 510(k) clearance on 1997-05-09 under 510(k) number K971327. 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 UNIKA?

UNIKA is a medical device that received FDA 510(k) clearance on 1997-05-09. The listed applicant is Eyewear Partners Co.. The 510(k) number is K971327.

When did UNIKA receive FDA 510(k) clearance?

UNIKA received FDA 510(k) clearance on 1997-05-09, under 510(k) number K971327.

Who is the listed applicant for UNIKA?

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

What is the FDA product code for UNIKA?

The FDA product code for UNIKA is HQY.

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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.

K974852NON-PRESCRIPTION SUNGLASSESChia Hui Spectacles Mfg. Corp.K974860NON-PRESCRIPTION SUNGLASSESWenzhou Ming Ming Optical Co. , Ltd.K974861NON-PRESCRIPTION SUNGLASSESWenzhou Hindar Optical Co., Ltd.K974511SUNGLASSESSun World Intl., Inc.K974441SUNGLASSESHip Shing Fat Co., Ltd.K973528SUNGLASSESJeou Jeou Long Industrial Co., Ltd.

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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