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FDA 510(k)

VISITEC IRRIGATION CONTROL SYSTEM

K-Number: K853243 · 1985-09-11

ApplicantVisitec Co.
Decision Date1985-09-11
Product CodeKYG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VISITEC IRRIGATION CONTROL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Visitec Co.. It received FDA 510(k) clearance on 1985-09-11 under 510(k) number K853243. 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 VISITEC IRRIGATION CONTROL SYSTEM?

VISITEC IRRIGATION CONTROL SYSTEM is a medical device that received FDA 510(k) clearance on 1985-09-11. The listed applicant is Visitec Co.. The 510(k) number is K853243.

When did VISITEC IRRIGATION CONTROL SYSTEM receive FDA 510(k) clearance?

VISITEC IRRIGATION CONTROL SYSTEM received FDA 510(k) clearance on 1985-09-11, under 510(k) number K853243.

Who is the listed applicant for VISITEC IRRIGATION CONTROL SYSTEM?

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

What is the FDA product code for VISITEC IRRIGATION CONTROL SYSTEM?

The FDA product code for VISITEC IRRIGATION CONTROL SYSTEM is KYG.

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Other records listing Visitec Co. 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.

K953394VISITEC COLLAR BUTTON CATHETER {GRIFFITHS}K945114VISITEC SCLERAL PLUGK945738VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPEK945172VISITEC SILICONE RETINAL IMPLANTS/EXPLANTSK942234VISITEC PRECISE-POINTK934269FIBEROPTIC ILLUMINATED INSTRUMENTS

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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.K980647EYE IRRIGATOR MODEL #2020Eye-Deal Ocular Safety Products, Inc.K974561MOISTAIR FLUID AIR TUBING SETAmerican Medical Devices, 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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