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FDA 510(k)

SPECTACLES FRAME

K-Number: K860954 · 1986-03-31

ApplicantRoseburg SA
Decision Date1986-03-31
Product CodeHQZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SPECTACLES FRAME is the device name listed in this FDA 510(k) record. The listed applicant is Roseburg SA. It received FDA 510(k) clearance on 1986-03-31 under 510(k) number K860954. 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 SPECTACLES FRAME?

SPECTACLES FRAME is a medical device that received FDA 510(k) clearance on 1986-03-31. The listed applicant is Roseburg SA. The 510(k) number is K860954.

When did SPECTACLES FRAME receive FDA 510(k) clearance?

SPECTACLES FRAME received FDA 510(k) clearance on 1986-03-31, under 510(k) number K860954.

Who is the listed applicant for SPECTACLES FRAME?

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

What is the FDA product code for SPECTACLES FRAME?

The FDA product code for SPECTACLES FRAME is HQZ.

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Other records listing Roseburg SA 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.

K931155STAPLE, FIXATION BONE; SCREW FIXATION BONEK890081CALIUS-ISABEL CANOVAS SUNGLASSESK885275ASSENAT-BLESCHET SUNGLASSESK882392BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVESK872715UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERYK874317POIRIER KID-ROLLER MANUAL WHEELCHAIR

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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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