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FDA 510(k)

O.M.S. ULTRA-PHACO

K-Number: K844373 · 1985-12-19

ApplicantOptical Micro Systems, Inc.
Decision Date1985-12-19
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

O.M.S. ULTRA-PHACO is the device name listed in this FDA 510(k) record. The listed applicant is Optical Micro Systems, Inc.. It received FDA 510(k) clearance on 1985-12-19 under 510(k) number K844373. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the O.M.S. ULTRA-PHACO?

O.M.S. ULTRA-PHACO is a medical device that received FDA 510(k) clearance on 1985-12-19. The listed applicant is Optical Micro Systems, Inc.. The 510(k) number is K844373.

When did O.M.S. ULTRA-PHACO receive FDA 510(k) clearance?

O.M.S. ULTRA-PHACO received FDA 510(k) clearance on 1985-12-19, under 510(k) number K844373.

Who is the listed applicant for O.M.S. ULTRA-PHACO?

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

What is the FDA product code for O.M.S. ULTRA-PHACO?

The FDA product code for O.M.S. ULTRA-PHACO is HQC.

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Other records listing Optical Micro Systems, Inc. as applicant

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K950218OMS SLIMLINE PHACO HANDPIECEK946054DIPLOMAXK935223OPHTHALMIC SURGICAL SYSTEMK935226I/V POLEK935003ELECTRIC I/V POLE OR EIVP2K870068ASPIRATION REVERSAL CONTROL (ARC) MODULE

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Related Devices (Code: HQC)

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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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