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FDA 510(k)

OPTIM-EYES 450

K-Number: K971875 · 1997-06-13

ApplicantTaylor/Fox Enterprises, LLC
Decision Date1997-06-13
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPTIM-EYES 450 is the device name listed in this FDA 510(k) record. The listed applicant is Taylor/Fox Enterprises, LLC. It received FDA 510(k) clearance on 1997-06-13 under 510(k) number K971875. 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 OPTIM-EYES 450?

OPTIM-EYES 450 is a medical device that received FDA 510(k) clearance on 1997-06-13. The listed applicant is Taylor/Fox Enterprises, LLC. The 510(k) number is K971875.

When did OPTIM-EYES 450 receive FDA 510(k) clearance?

OPTIM-EYES 450 received FDA 510(k) clearance on 1997-06-13, under 510(k) number K971875.

Who is the listed applicant for OPTIM-EYES 450?

The FDA 510(k) record lists Taylor/Fox Enterprises, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPTIM-EYES 450?

The FDA product code for OPTIM-EYES 450 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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