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FDA 510(k)

OPTHALMIC BAR PRISM

K-Number: K851555 · 1985-05-23

ApplicantRoseburg SA
Decision Date1985-05-23
Product CodeHKW
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPTHALMIC BAR PRISM is the device name listed in this FDA 510(k) record. The listed applicant is Roseburg SA. It received FDA 510(k) clearance on 1985-05-23 under 510(k) number K851555. The device is classified under product code HKW. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTHALMIC BAR PRISM?

OPTHALMIC BAR PRISM is a medical device that received FDA 510(k) clearance on 1985-05-23. The listed applicant is Roseburg SA. The 510(k) number is K851555.

When did OPTHALMIC BAR PRISM receive FDA 510(k) clearance?

OPTHALMIC BAR PRISM received FDA 510(k) clearance on 1985-05-23, under 510(k) number K851555.

Who is the listed applicant for OPTHALMIC BAR PRISM?

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 OPTHALMIC BAR PRISM?

The FDA product code for OPTHALMIC BAR PRISM is HKW.

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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: HKW)

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.

K911374PLASTIC OVERLAYSNational Reading Service

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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