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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
510(k) Number K181071
Device Name SIRA RFA Electrosurgical Device
Applicant
Innoblative Designs, Inc.
4660 Ravenswood Ave.
Chicago,  IL  60640
Applicant Contact Tyler Wanke
Correspondent
Hogan Lovells US LLP
1735 Market St.,
23rd Floor
Philadelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/23/2018
Decision Date 01/16/2019
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
Predetermined Change
Control Plan Authorized		 No
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