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FDA 510(k)

EYE IRRIGATOR MODEL #2020

K-Number: K980647 · 1998-05-15

ApplicantEye-Deal Ocular Safety Products, Inc.
Decision Date1998-05-15
Product CodeKYG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

EYE IRRIGATOR MODEL #2020 is the device name listed in this FDA 510(k) record. The listed applicant is Eye-Deal Ocular Safety Products, Inc.. It received FDA 510(k) clearance on 1998-05-15 under 510(k) number K980647. The device is classified under product code KYG. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EYE IRRIGATOR MODEL #2020?

EYE IRRIGATOR MODEL #2020 is a medical device that received FDA 510(k) clearance on 1998-05-15. The listed applicant is Eye-Deal Ocular Safety Products, Inc.. The 510(k) number is K980647.

When did EYE IRRIGATOR MODEL #2020 receive FDA 510(k) clearance?

EYE IRRIGATOR MODEL #2020 received FDA 510(k) clearance on 1998-05-15, under 510(k) number K980647.

Who is the listed applicant for EYE IRRIGATOR MODEL #2020?

The FDA 510(k) record lists Eye-Deal Ocular Safety Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EYE IRRIGATOR MODEL #2020?

The FDA product code for EYE IRRIGATOR MODEL #2020 is KYG.

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Related Devices (Code: KYG)

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.

K010353MED-LOGICS DISPOSABLE ALK TUBINGMed-Logics, Inc.K003036TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025Retinalabs.ComK993591BLADEWORKS DISPOSABLE ALK TUBINGBlade Works, Inc.K981116SOVEREIGN CATARACT EXTRACTION SYSTEMAllergan, Inc.K974561MOISTAIR FLUID AIR TUBING SETAmerican Medical Devices, Inc.K971173ML DISPOSABLE ALK TUBINGMed-Logics, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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