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FDA 510(k)

OPTIKOS SHAMI, INC. SPECTACLE FRAMES

K-Number: K934198 · 1993-10-04

ApplicantOptikos Shami, Inc.
Decision Date1993-10-04
Product CodeHQZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPTIKOS SHAMI, INC. SPECTACLE FRAMES is the device name listed in this FDA 510(k) record. The listed applicant is Optikos Shami, Inc.. It received FDA 510(k) clearance on 1993-10-04 under 510(k) number K934198. The device is classified under product code HQZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTIKOS SHAMI, INC. SPECTACLE FRAMES?

OPTIKOS SHAMI, INC. SPECTACLE FRAMES is a medical device that received FDA 510(k) clearance on 1993-10-04. The listed applicant is Optikos Shami, Inc.. The 510(k) number is K934198.

When did OPTIKOS SHAMI, INC. SPECTACLE FRAMES receive FDA 510(k) clearance?

OPTIKOS SHAMI, INC. SPECTACLE FRAMES received FDA 510(k) clearance on 1993-10-04, under 510(k) number K934198.

Who is the listed applicant for OPTIKOS SHAMI, INC. SPECTACLE FRAMES?

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

What is the FDA product code for OPTIKOS SHAMI, INC. SPECTACLE FRAMES?

The FDA product code for OPTIKOS SHAMI, INC. SPECTACLE FRAMES is HQZ.

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 Optikos Shami, 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.

K934197OPTIKOS SHAMI, INC. SUNGLASSES

Related Devices (Code: HQZ)

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.

K952597VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, SUN POCKETS, POINT OF VIEWPoint of View Optical Outlet, Inc.K944313SPECTACLE FRAMESun Hing Optical Manufactory , Ltd.K945392SPECTACLE FRAMESeo Han Corp., Ltd.K945176SPECTACLE FRAME OR EYEGLASS FRAMESOptipia Trading Co.K945770OPTICAL FRAMESRamada Optics, Inc.K945350FRAME, SPECTACLESTaiwan Eva Industrial Co., Inc.

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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