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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Marker, Radiographic, Implantable
510(k) Number K181007
Device Name Cianna Medical SAVI Scout Reflector and SAVI Scout System
Applicant
Cianna Medical, Inc.
6 Journey, Suite 125
Aliso Viejo,  CA  92656
Applicant Contact Gary Mocnik
Correspondent
Cianna Medical, Inc.
6 Journey, Suite 125
Aliso Viejo,  CA  92656
Correspondent Contact Gary Mocnik
Regulation Number878.4300
Classification Product Code
NEU  
Date Received04/17/2018
Decision Date 08/02/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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