FDA 510(k)

VISITEC OPHTHALMIC FLUID DISTRIB- SET

K-Number: K843487 · 1985-03-13

Decision Date1985-03-13

Product CodeHQC

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

VISITEC OPHTHALMIC FLUID DISTRIB- SET is the device name listed in this FDA 510(k) record. The listed applicant is Visitec Co.. It received FDA 510(k) clearance on 1985-03-13 under 510(k) number K843487. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISITEC OPHTHALMIC FLUID DISTRIB- SET?

VISITEC OPHTHALMIC FLUID DISTRIB- SET is a medical device that received FDA 510(k) clearance on 1985-03-13. The listed applicant is Visitec Co.. The 510(k) number is K843487.

When did VISITEC OPHTHALMIC FLUID DISTRIB- SET receive FDA 510(k) clearance?

VISITEC OPHTHALMIC FLUID DISTRIB- SET received FDA 510(k) clearance on 1985-03-13, under 510(k) number K843487.

Who is the listed applicant for VISITEC OPHTHALMIC FLUID DISTRIB- SET?

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 OPHTHALMIC FLUID DISTRIB- SET?

The FDA product code for VISITEC OPHTHALMIC FLUID DISTRIB- SET is HQC.

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Other records listing Visitec Co. as applicant

K953394VISITEC COLLAR BUTTON CATHETER {GRIFFITHS}K945114VISITEC SCLERAL PLUG K945738VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE K945172VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS K942234VISITEC PRECISE-POINT K934269FIBEROPTIC ILLUMINATED INSTRUMENTS

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Related Devices (Code: HQC)

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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.