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FDA 510(k)

D.O.R.C. VFI/VFE SYSTEM

K-Number: K954842 · 1996-04-15

ApplicantDutch Ophthalmic USA, Inc.
Decision Date1996-04-15
Product CodeKYG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

D.O.R.C. VFI/VFE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dutch Ophthalmic USA, Inc.. It received FDA 510(k) clearance on 1996-04-15 under 510(k) number K954842. 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 D.O.R.C. VFI/VFE SYSTEM?

D.O.R.C. VFI/VFE SYSTEM is a medical device that received FDA 510(k) clearance on 1996-04-15. The listed applicant is Dutch Ophthalmic USA, Inc.. The 510(k) number is K954842.

When did D.O.R.C. VFI/VFE SYSTEM receive FDA 510(k) clearance?

D.O.R.C. VFI/VFE SYSTEM received FDA 510(k) clearance on 1996-04-15, under 510(k) number K954842.

Who is the listed applicant for D.O.R.C. VFI/VFE SYSTEM?

The FDA 510(k) record lists Dutch Ophthalmic USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for D.O.R.C. VFI/VFE SYSTEM?

The FDA product code for D.O.R.C. VFI/VFE SYSTEM is KYG.

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Other records listing Dutch Ophthalmic USA, 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.

K012821D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEMK010082D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEMK983797D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEMK980636FIBER OPTIC ENDOILLUMINATION PROBEK973229D.O.R.C. HEXON ILLUMINATION SYSTEMK973757D.O.R.C. SOLUX LIGHT SOURCE

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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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