FDA 510(k)

KONTUR 55 SOFT LENS

K-Number: K001908 · 2000-08-18

Decision Date2000-08-18

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

KONTUR 55 SOFT LENS is the device name listed in this FDA 510(k) record. The listed applicant is Kontur Kontact Lens Co., Inc.. It received FDA 510(k) clearance on 2000-08-18 under 510(k) number K001908. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KONTUR 55 SOFT LENS?

KONTUR 55 SOFT LENS is a medical device that received FDA 510(k) clearance on 2000-08-18. The listed applicant is Kontur Kontact Lens Co., Inc.. The 510(k) number is K001908.

When did KONTUR 55 SOFT LENS receive FDA 510(k) clearance?

KONTUR 55 SOFT LENS received FDA 510(k) clearance on 2000-08-18, under 510(k) number K001908.

Who is the listed applicant for KONTUR 55 SOFT LENS?

The FDA 510(k) record lists Kontur Kontact Lens Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KONTUR 55 SOFT LENS?

The FDA product code for KONTUR 55 SOFT LENS is LPL.

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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.