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FDA 510(k)

GALLIE CRYONUCLEATOR

K-Number: K833747 · 1984-05-09

ApplicantMono Research Laboratories
Decision Date1984-05-09
Product CodeHPS
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

GALLIE CRYONUCLEATOR is the device name listed in this FDA 510(k) record. The listed applicant is Mono Research Laboratories. It received FDA 510(k) clearance on 1984-05-09 under 510(k) number K833747. The device is classified under product code HPS. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GALLIE CRYONUCLEATOR?

GALLIE CRYONUCLEATOR is a medical device that received FDA 510(k) clearance on 1984-05-09. The listed applicant is Mono Research Laboratories. The 510(k) number is K833747.

When did GALLIE CRYONUCLEATOR receive FDA 510(k) clearance?

GALLIE CRYONUCLEATOR received FDA 510(k) clearance on 1984-05-09, under 510(k) number K833747.

Who is the listed applicant for GALLIE CRYONUCLEATOR?

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

What is the FDA product code for GALLIE CRYONUCLEATOR?

The FDA product code for GALLIE CRYONUCLEATOR is HPS.

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Related Devices (Code: HPS)

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.

K202038CryoTreQVitreQ BVK940373OPHTHALMIC CRYO UNITDutch Ophthalmic USA, Inc.K923629OPHTHALMIC TRICHIASIS PROBEMira, Inc.K903303SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBESSpembly Medical , Ltd.K874555KEELER ACU 22XT OPHTHALMIC CRYO UNITKeeler Instruments, Inc.K873388KEELER CTU CRYO SYSTEMKeeler Instruments, 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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