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FDA 510(k)

SUNGLASSES (NON-PRESCRIPTION)

K-Number: K860953 · 1986-10-24

ApplicantRoseburg SA
Decision Date1986-10-24
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SUNGLASSES (NON-PRESCRIPTION) is the device name listed in this FDA 510(k) record. The listed applicant is Roseburg SA. It received FDA 510(k) clearance on 1986-10-24 under 510(k) number K860953. 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 SUNGLASSES (NON-PRESCRIPTION)?

SUNGLASSES (NON-PRESCRIPTION) is a medical device that received FDA 510(k) clearance on 1986-10-24. The listed applicant is Roseburg SA. The 510(k) number is K860953.

When did SUNGLASSES (NON-PRESCRIPTION) receive FDA 510(k) clearance?

SUNGLASSES (NON-PRESCRIPTION) received FDA 510(k) clearance on 1986-10-24, under 510(k) number K860953.

Who is the listed applicant for SUNGLASSES (NON-PRESCRIPTION)?

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 SUNGLASSES (NON-PRESCRIPTION)?

The FDA product code for SUNGLASSES (NON-PRESCRIPTION) 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 BONEK890081CALIUS-ISABEL CANOVAS SUNGLASSESK885275ASSENAT-BLESCHET SUNGLASSESK882392BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVESK872715UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERYK874317POIRIER KID-ROLLER MANUAL WHEELCHAIR

View all 24 devices →

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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