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FDA 510(k)

OPHTHALMIC SURGICAL OCULAR MARKERS

K-Number: K863663 · 1986-10-20

ApplicantMyocure, Inc.
Decision Date1986-10-20
Product CodeHMR
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPHTHALMIC SURGICAL OCULAR MARKERS is the device name listed in this FDA 510(k) record. The listed applicant is Myocure, Inc.. It received FDA 510(k) clearance on 1986-10-20 under 510(k) number K863663. The device is classified under product code HMR. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPHTHALMIC SURGICAL OCULAR MARKERS?

OPHTHALMIC SURGICAL OCULAR MARKERS is a medical device that received FDA 510(k) clearance on 1986-10-20. The listed applicant is Myocure, Inc.. The 510(k) number is K863663.

When did OPHTHALMIC SURGICAL OCULAR MARKERS receive FDA 510(k) clearance?

OPHTHALMIC SURGICAL OCULAR MARKERS received FDA 510(k) clearance on 1986-10-20, under 510(k) number K863663.

Who is the listed applicant for OPHTHALMIC SURGICAL OCULAR MARKERS?

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

What is the FDA product code for OPHTHALMIC SURGICAL OCULAR MARKERS?

The FDA product code for OPHTHALMIC SURGICAL OCULAR MARKERS is HMR.

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Other records listing Myocure, Inc. 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.

K880345CYSTOTOMES/KNIFESK880347ANESTHESIA/RETROBULBAR NEEDLESK880346CANNULASK874057OPHTHALMIC TIP & BLADE SCALPELSK874056OPHTHALMIC DISPOSABLE BLADESK873385OPHTHALMIC PHACO-BLADE

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Related Devices (Code: HMR)

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.

K053475OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450Refractec, Inc.K925606OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERSChiron Vision Corp.K872747LASER CENTERING DEVICEInnomed Corp.K861535OPTICAL MARKERS/FIXATION RING/CANNU & IRRIGA CANNUCooperVision, 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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