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FDA 510(k)

NORMA KAMLALI/ALFRED SUNG/ROOTS OF CANADA/STEEL MAXX SUNGLASS

K-Number: K973016 · 1997-09-17

ApplicantOptimaxx Intl.
Decision Date1997-09-17
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

NORMA KAMLALI/ALFRED SUNG/ROOTS OF CANADA/STEEL MAXX SUNGLASS is the device name listed in this FDA 510(k) record. The listed applicant is Optimaxx Intl.. It received FDA 510(k) clearance on 1997-09-17 under 510(k) number K973016. 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 NORMA KAMLALI/ALFRED SUNG/ROOTS OF CANADA/STEEL MAXX SUNGLASS?

NORMA KAMLALI/ALFRED SUNG/ROOTS OF CANADA/STEEL MAXX SUNGLASS is a medical device that received FDA 510(k) clearance on 1997-09-17. The listed applicant is Optimaxx Intl.. The 510(k) number is K973016.

When did NORMA KAMLALI/ALFRED SUNG/ROOTS OF CANADA/STEEL MAXX SUNGLASS receive FDA 510(k) clearance?

NORMA KAMLALI/ALFRED SUNG/ROOTS OF CANADA/STEEL MAXX SUNGLASS received FDA 510(k) clearance on 1997-09-17, under 510(k) number K973016.

Who is the listed applicant for NORMA KAMLALI/ALFRED SUNG/ROOTS OF CANADA/STEEL MAXX SUNGLASS?

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

What is the FDA product code for NORMA KAMLALI/ALFRED SUNG/ROOTS OF CANADA/STEEL MAXX SUNGLASS?

The FDA product code for NORMA KAMLALI/ALFRED SUNG/ROOTS OF CANADA/STEEL MAXX SUNGLASS is HQY.

Related Clinical Trials

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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