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FDA 510(k)

OMYL -ARDE- SPECTACLE FRAME

K-Number: K833401 · 1984-02-21

ApplicantI.J. Langleb , Ltd.
Decision Date1984-02-21
Product CodeHQZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OMYL -ARDE- SPECTACLE FRAME is the device name listed in this FDA 510(k) record. The listed applicant is I.J. Langleb , Ltd.. It received FDA 510(k) clearance on 1984-02-21 under 510(k) number K833401. 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 OMYL -ARDE- SPECTACLE FRAME?

OMYL -ARDE- SPECTACLE FRAME is a medical device that received FDA 510(k) clearance on 1984-02-21. The listed applicant is I.J. Langleb , Ltd.. The 510(k) number is K833401.

When did OMYL -ARDE- SPECTACLE FRAME receive FDA 510(k) clearance?

OMYL -ARDE- SPECTACLE FRAME received FDA 510(k) clearance on 1984-02-21, under 510(k) number K833401.

Who is the listed applicant for OMYL -ARDE- SPECTACLE FRAME?

The FDA 510(k) record lists I.J. Langleb , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OMYL -ARDE- SPECTACLE FRAME?

The FDA product code for OMYL -ARDE- SPECTACLE FRAME is HQZ.

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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

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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