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FDA 510(k)

ION MEDICAL BIPOLAR COAGULATION PEN

K-Number: K072911 · 2007-12-13

ApplicantIon Medical, LLC
Decision Date2007-12-13
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ION MEDICAL BIPOLAR COAGULATION PEN is the device name listed in this FDA 510(k) record. The listed applicant is Ion Medical, LLC. It received FDA 510(k) clearance on 2007-12-13 under 510(k) number K072911. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ION MEDICAL BIPOLAR COAGULATION PEN?

ION MEDICAL BIPOLAR COAGULATION PEN is a medical device that received FDA 510(k) clearance on 2007-12-13. The listed applicant is Ion Medical, LLC. The 510(k) number is K072911.

When did ION MEDICAL BIPOLAR COAGULATION PEN receive FDA 510(k) clearance?

ION MEDICAL BIPOLAR COAGULATION PEN received FDA 510(k) clearance on 2007-12-13, under 510(k) number K072911.

Who is the listed applicant for ION MEDICAL BIPOLAR COAGULATION PEN?

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

What is the FDA product code for ION MEDICAL BIPOLAR COAGULATION PEN?

The FDA product code for ION MEDICAL BIPOLAR COAGULATION PEN is GEI.

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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.

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