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FDA 510(k)

CUSTOM OPTICAL SUNGLASS FRAMES

K-Number: K970895 · 1997-05-06

ApplicantCustom Optical Frames, Inc.
Decision Date1997-05-06
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CUSTOM OPTICAL SUNGLASS FRAMES is the device name listed in this FDA 510(k) record. The listed applicant is Custom Optical Frames, Inc.. It received FDA 510(k) clearance on 1997-05-06 under 510(k) number K970895. 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 CUSTOM OPTICAL SUNGLASS FRAMES?

CUSTOM OPTICAL SUNGLASS FRAMES is a medical device that received FDA 510(k) clearance on 1997-05-06. The listed applicant is Custom Optical Frames, Inc.. The 510(k) number is K970895.

When did CUSTOM OPTICAL SUNGLASS FRAMES receive FDA 510(k) clearance?

CUSTOM OPTICAL SUNGLASS FRAMES received FDA 510(k) clearance on 1997-05-06, under 510(k) number K970895.

Who is the listed applicant for CUSTOM OPTICAL SUNGLASS FRAMES?

The FDA 510(k) record lists Custom Optical Frames, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CUSTOM OPTICAL SUNGLASS FRAMES?

The FDA product code for CUSTOM OPTICAL SUNGLASS FRAMES 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Custom Optical Frames, Inc. 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.

K962478(BRAND NAME) SUNGLASS FRAMESK944373SPECTACLE FRAMESK925224U108, U105, G209-B

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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