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FDA 510(k)

700-123 EYE SHADE

K-Number: K853043 · 1985-12-13

ApplicantHealth Saver Products
Decision Date1985-12-13
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

700-123 EYE SHADE is the device name listed in this FDA 510(k) record. The listed applicant is Health Saver Products. It received FDA 510(k) clearance on 1985-12-13 under 510(k) number K853043. 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 700-123 EYE SHADE?

700-123 EYE SHADE is a medical device that received FDA 510(k) clearance on 1985-12-13. The listed applicant is Health Saver Products. The 510(k) number is K853043.

When did 700-123 EYE SHADE receive FDA 510(k) clearance?

700-123 EYE SHADE received FDA 510(k) clearance on 1985-12-13, under 510(k) number K853043.

Who is the listed applicant for 700-123 EYE SHADE?

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

What is the FDA product code for 700-123 EYE SHADE?

The FDA product code for 700-123 EYE SHADE 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.

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Other records listing Health Saver Products 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.

K861333ULTRA-VIOLET GOGGLETS

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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