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FDA 510(k)

CALIUS-ISABEL CANOVAS SUNGLASSES

K-Number: K890081 · 1989-03-09

ApplicantRoseburg SA
Decision Date1989-03-09
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CALIUS-ISABEL CANOVAS SUNGLASSES is the device name listed in this FDA 510(k) record. The listed applicant is Roseburg SA. It received FDA 510(k) clearance on 1989-03-09 under 510(k) number K890081. 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 CALIUS-ISABEL CANOVAS SUNGLASSES?

CALIUS-ISABEL CANOVAS SUNGLASSES is a medical device that received FDA 510(k) clearance on 1989-03-09. The listed applicant is Roseburg SA. The 510(k) number is K890081.

When did CALIUS-ISABEL CANOVAS SUNGLASSES receive FDA 510(k) clearance?

CALIUS-ISABEL CANOVAS SUNGLASSES received FDA 510(k) clearance on 1989-03-09, under 510(k) number K890081.

Who is the listed applicant for CALIUS-ISABEL CANOVAS SUNGLASSES?

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 CALIUS-ISABEL CANOVAS SUNGLASSES?

The FDA product code for CALIUS-ISABEL CANOVAS SUNGLASSES is HQY.

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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 BONEK885275ASSENAT-BLESCHET SUNGLASSESK882392BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVESK872715UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERYK874317POIRIER KID-ROLLER MANUAL WHEELCHAIRK872714S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY

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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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