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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 K192112
Device Name FlexBand Plus
Applicant
International Life Sciences
2252 Northwest Pkwy. SE
Marietta,  GA  30067
Applicant Contact Tiffini Wittwer
Correspondent
International Life Sciences
2252 Northwest Pkwy. SE
Marietta,  GA  30067
Correspondent Contact Tiffini Wittwer
Regulation Number878.3300
Classification Product Code
FTL  
Date Received08/05/2019
Decision Date 09/27/2019
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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