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FDA 510(k)

EYE-VAC

K-Number: K801231 · 1980-07-21

ApplicantCoburn Optical Ind., Inc.
Decision Date1980-07-21
Product CodeHKP
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

EYE-VAC is the device name listed in this FDA 510(k) record. The listed applicant is Coburn Optical Ind., Inc.. It received FDA 510(k) clearance on 1980-07-21 under 510(k) number K801231. 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 EYE-VAC?

EYE-VAC is a medical device that received FDA 510(k) clearance on 1980-07-21. The listed applicant is Coburn Optical Ind., Inc.. The 510(k) number is K801231.

When did EYE-VAC receive FDA 510(k) clearance?

EYE-VAC received FDA 510(k) clearance on 1980-07-21, under 510(k) number K801231.

Who is the listed applicant for EYE-VAC?

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

What is the FDA product code for EYE-VAC?

The FDA product code for EYE-VAC is HKP.

Other records listing Coburn Optical Ind., Inc. 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.

K892348MAGNILINK SYSTEM 201K892347MAGNILINK SYSTEM 101K892350MAGNILINK SYSTEM 402/5K892349MAGNILINK SYSTEM 209K892351MAGNILINK SYSTEM 602K862188IRRIGATION & ASPIRATION/VITRECTOMY DEVICE

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Related Devices (Code: HKP)

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.

K952558AARON VAC 2Aaron Medical IndustriesK950056THE 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.

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