FDA 510(k)

REFLECTION, TANDEM UNIPOLAR

K-Number: K071160 · 2007-10-05

Decision Date2007-10-05

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

REFLECTION, TANDEM UNIPOLAR is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2007-10-05 under 510(k) number K071160. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REFLECTION, TANDEM UNIPOLAR?

REFLECTION, TANDEM UNIPOLAR is a medical device that received FDA 510(k) clearance on 2007-10-05. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K071160.

When did REFLECTION, TANDEM UNIPOLAR receive FDA 510(k) clearance?

REFLECTION, TANDEM UNIPOLAR received FDA 510(k) clearance on 2007-10-05, under 510(k) number K071160.

Who is the listed applicant for REFLECTION, TANDEM UNIPOLAR?

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

What is the FDA product code for REFLECTION, TANDEM UNIPOLAR?

The FDA product code for REFLECTION, TANDEM UNIPOLAR is LPH.

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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.