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FDA 510(k)

OPTEON UNIPOLAR

K-Number: K960538 · 1996-03-27

ApplicantExactech, Inc.
Decision Date1996-03-27
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OPTEON UNIPOLAR is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 1996-03-27 under 510(k) number K960538. The device is classified under product code KWL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTEON UNIPOLAR?

OPTEON UNIPOLAR is a medical device that received FDA 510(k) clearance on 1996-03-27. The listed applicant is Exactech, Inc.. The 510(k) number is K960538.

When did OPTEON UNIPOLAR receive FDA 510(k) clearance?

OPTEON UNIPOLAR received FDA 510(k) clearance on 1996-03-27, under 510(k) number K960538.

Who is the listed applicant for OPTEON UNIPOLAR?

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

What is the FDA product code for OPTEON UNIPOLAR?

The FDA product code for OPTEON UNIPOLAR is KWL.

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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.

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