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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 K162770
Device Name Relign System
Applicant
Relign Corporation
1601 South De Anza Boulevard, Suite 200
Cupertino,  CA  95014
Applicant Contact Nathan Nguyen
Correspondent
Relign Corporation
1601 South De Anza Boulevard, Suite 200
Cupertino,  CA  95014
Correspondent Contact Nathan Nguyen
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
HRX  
Date Received10/03/2016
Decision Date 01/04/2017
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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