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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Marker, Radiographic, Implantable
510(k) Number K192371
Device Name BioZorb SP Marker
Applicant
Focal Therapeutics
1010 Stewart Dr.
Sunnyvale,  CA  94085
Applicant Contact Dhaval Saraiya
Correspondent
Focal Therapeutics
1010 Stewart Dr.
Sunnyvale,  CA  94085
Correspondent Contact Dhaval Saraiya
Regulation Number878.4300
Classification Product Code
NEU  
Date Received08/30/2019
Decision Date 09/26/2019
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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