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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Internal Tissue Marker
510(k) Number K141318
Device Name CIANNA MEDICAL SGS SYSTEM
Applicant
Cianna Medical, Inc.
6 Journey, Suite 125
Aliso Viejo,  CA  92656
Applicant Contact GARY MONCNIK
Correspondent
Cianna Medical, Inc.
6 Journey, Suite 125
Aliso Viejo,  CA  92656
Correspondent Contact GARY MOCNIK
Regulation Number878.4670
Classification Product Code
PDW  
Date Received05/20/2014
Decision Date 08/27/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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