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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrosurgical, cutting & coagulation accessories, laparoscopic & endoscopic, reprocessed
510(k) Number K173741
Device Name Reprocessed ArthoCare Ablation Wand
Applicant
ReNovo, Inc.
340 SW Columbia St.
Bend,  OR  97702
Applicant Contact Mark K. Wells
Correspondent
Medical Device Academy, Inc.
345 Lincoln Hill Rd.
Shrewsbury,  VT  05738
Correspondent Contact Robert V. Packard
Regulation Number878.4400
Classification Product Code
NUJ  
Date Received12/07/2017
Decision Date 03/05/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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