FDA 510(k)

OCUTOME MODEL 8000

K-Number: K791898 · 1979-10-30

Decision Date1979-10-30

Product CodeHKP

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

OCUTOME MODEL 8000 is the device name listed in this FDA 510(k) record. The listed applicant is Cooper Medical Devices Corp.. It received FDA 510(k) clearance on 1979-10-30 under 510(k) number K791898. The device is classified under product code HKP. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OCUTOME MODEL 8000?

OCUTOME MODEL 8000 is a medical device that received FDA 510(k) clearance on 1979-10-30. The listed applicant is Cooper Medical Devices Corp.. The 510(k) number is K791898.

When did OCUTOME MODEL 8000 receive FDA 510(k) clearance?

OCUTOME MODEL 8000 received FDA 510(k) clearance on 1979-10-30, under 510(k) number K791898.

Who is the listed applicant for OCUTOME MODEL 8000?

The FDA 510(k) record lists Cooper Medical Devices Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OCUTOME MODEL 8000?

The FDA product code for OCUTOME MODEL 8000 is HKP.

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Other records listing Cooper Medical Devices Corp. as applicant

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Related Devices (Code: HKP)

K952558AARON VAC 2Aaron Medical Industries K950056THE GRIESHABER AXIAL CUTTERGrieshaber & Co.K950287UNIVIT PROBEMedical Instrument Development Laboratories, Inc.K896622VISITEC VITRECTOMY UNITVisitec Co.K890595MENTOR ANTERIOR SEGMENT VITRECTORMentor O & O, Inc.K832074CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRACooperVision, 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.