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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
510(k) Number K172545
Device Name SERI Contour
Applicant
Sofregen Medical, Inc.
200 Boston Ave.
Suite 1100
Medford,  MA  02155
Applicant Contact Anh Hoang
Correspondent
Sofregen Medical, Inc.
200 Boston Ave.
Suite 1100
Medford,  MA  02155
Correspondent Contact Anh Hoang
Regulation Number878.3300
Classification Product Code
OXF  
Date Received08/23/2017
Decision Date 09/22/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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