FDA 510(k) Application Details - K211203

Device Classification Name Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

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510(K) Number K211203
Device Name Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Applicant Green OR, LLC.
4200 Dahlberg Drive #300
Golden Valley, MN 55422 US
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Contact John Zehren
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Regulation Number 878.4400

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Classification Product Code NUJ
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Date Received 04/22/2021
Decision Date 04/07/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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