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FDA 510(k)

AURORA SUNGLASSES,SKI GOGGLES AND PROTECTIVE/SAFTEY GOGGLES

K-Number: K970699 · 1997-05-13

ApplicantYeong Jiuh Corp.
Decision Date1997-05-13
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

AURORA SUNGLASSES,SKI GOGGLES AND PROTECTIVE/SAFTEY GOGGLES is the device name listed in this FDA 510(k) record. The listed applicant is Yeong Jiuh Corp.. It received FDA 510(k) clearance on 1997-05-13 under 510(k) number K970699. 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 AURORA SUNGLASSES,SKI GOGGLES AND PROTECTIVE/SAFTEY GOGGLES?

AURORA SUNGLASSES,SKI GOGGLES AND PROTECTIVE/SAFTEY GOGGLES is a medical device that received FDA 510(k) clearance on 1997-05-13. The listed applicant is Yeong Jiuh Corp.. The 510(k) number is K970699.

When did AURORA SUNGLASSES,SKI GOGGLES AND PROTECTIVE/SAFTEY GOGGLES receive FDA 510(k) clearance?

AURORA SUNGLASSES,SKI GOGGLES AND PROTECTIVE/SAFTEY GOGGLES received FDA 510(k) clearance on 1997-05-13, under 510(k) number K970699.

Who is the listed applicant for AURORA SUNGLASSES,SKI GOGGLES AND PROTECTIVE/SAFTEY GOGGLES?

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

What is the FDA product code for AURORA SUNGLASSES,SKI GOGGLES AND PROTECTIVE/SAFTEY GOGGLES?

The FDA product code for AURORA SUNGLASSES,SKI GOGGLES AND PROTECTIVE/SAFTEY GOGGLES 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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