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FDA 510(k)

OPHTHALMIC SURGICAL INSTRUMENTS

K-Number: K864183 · 1986-11-28

ApplicantTechno Ophthalmics Intl.
Decision Date1986-11-28
Product CodeHNR
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPHTHALMIC SURGICAL INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Techno Ophthalmics Intl.. It received FDA 510(k) clearance on 1986-11-28 under 510(k) number K864183. The device is classified under product code HNR. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPHTHALMIC SURGICAL INSTRUMENTS?

OPHTHALMIC SURGICAL INSTRUMENTS is a medical device that received FDA 510(k) clearance on 1986-11-28. The listed applicant is Techno Ophthalmics Intl.. The 510(k) number is K864183.

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

OPHTHALMIC SURGICAL INSTRUMENTS received FDA 510(k) clearance on 1986-11-28, under 510(k) number K864183.

Who is the listed applicant for OPHTHALMIC SURGICAL INSTRUMENTS?

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

What is the FDA product code for OPHTHALMIC SURGICAL INSTRUMENTS?

The FDA product code for OPHTHALMIC SURGICAL INSTRUMENTS is HNR.

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Related Devices (Code: HNR)

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.

K022835STEPHENS DISPOSABLE FORCEPSStephens InstrumentsK895434ALCON FOLDING FORCEPSAlcon LaboratoriesK891487SOFT LENS FOLDING BLOCKWestern Medical Products, Inc.K893199PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTRAllergan Medical OpticsK885230MCDONALD FOLDING FORCEPSAlcon LaboratoriesK881049BRADBURY INTRAOCULAR RETINAL KIT CAT #200Microline Pentax, 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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