FDA 510(k)

LANE ONE

K-Number: K832770 · 1983-09-26

Decision Date1983-09-26

Product CodeIKK

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

LANE ONE is the device name listed in this FDA 510(k) record. The listed applicant is Loredan Biomedical, Inc.. It received FDA 510(k) clearance on 1983-09-26 under 510(k) number K832770. The device is classified under product code IKK. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LANE ONE?

LANE ONE is a medical device that received FDA 510(k) clearance on 1983-09-26. The listed applicant is Loredan Biomedical, Inc.. The 510(k) number is K832770.

When did LANE ONE receive FDA 510(k) clearance?

LANE ONE received FDA 510(k) clearance on 1983-09-26, under 510(k) number K832770.

Who is the listed applicant for LANE ONE?

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

What is the FDA product code for LANE ONE?

The FDA product code for LANE ONE is IKK.

Other records listing Loredan Biomedical, Inc. as applicant

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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.