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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, Polymeric
510(k) Number K200918
Device Name SurgiWrap FROST
Applicant
Mast Biosurgery
6749 Top Gun St. Suite 108
San Diego,  CA  92121
Applicant Contact Roel Trip
Correspondent
QSR Consulting
10807 Dakota Ranch Rd.
Santee,  CA  92071
Correspondent Contact Kenneth K. Kleinhenz
Regulation Number878.3300
Classification Product Code
FTL  
Date Received04/06/2020
Decision Date 01/07/2021
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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