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FDA 510(k)

PLANCON MIRCOLAMELLAR KERATOME

K-Number: K960395 · 1996-04-26

ApplicantPlancon Instruments
Decision Date1996-04-26
Product CodeHNO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PLANCON MIRCOLAMELLAR KERATOME is the device name listed in this FDA 510(k) record. The listed applicant is Plancon Instruments. It received FDA 510(k) clearance on 1996-04-26 under 510(k) number K960395. The device is classified under product code HNO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLANCON MIRCOLAMELLAR KERATOME?

PLANCON MIRCOLAMELLAR KERATOME is a medical device that received FDA 510(k) clearance on 1996-04-26. The listed applicant is Plancon Instruments. The 510(k) number is K960395.

When did PLANCON MIRCOLAMELLAR KERATOME receive FDA 510(k) clearance?

PLANCON MIRCOLAMELLAR KERATOME received FDA 510(k) clearance on 1996-04-26, under 510(k) number K960395.

Who is the listed applicant for PLANCON MIRCOLAMELLAR KERATOME?

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

What is the FDA product code for PLANCON MIRCOLAMELLAR KERATOME?

The FDA product code for PLANCON MIRCOLAMELLAR KERATOME is HNO.

Related Clinical Trials

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.

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Other records listing Plancon Instruments 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.

K980924PLANCON MICROLAMELLAR KERATOME EVOLUTIONK970377PLANCON MICROLAMELLAR KERATOME (SINGLE PIECE KERATOME HEAD WITH ACCESSORIES)

Related Devices (Code: HNO)

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.

K173371VisuMax Femtosecond LaserCarl Zeiss Meditec, Inc.K172994EPI K ConsoleMoria SAK072102EPIVISION SL SYSTEMGebauer Medizintechnik GmbHK082043CARRIAZO-PENDULAR MICROKERATOMESchwind Eye-Tech-Solutions GmbH & Co. KGK062465ZYOPTIX XP EPI SEPARATOR SYSTEMBausch & Lomb, Inc.K052891HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEMHawken Industries

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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