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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
510(k) Number K200748
Device Name Visby Medical Sexual Health
Applicant
Visby Medical
3010 N. First St.
San Jose,  CA  95134
Applicant Contact Carolyn Glickman
Correspondent
Visby Medical
3010 N. First St.
San Jose,  CA  95134
Correspondent Contact Beth Lingenfelter
Classification Product Code
QEP  
Subsequent Product Codes
LSL   MKZ   OUY  
Date Received03/23/2020
Decision Date 08/26/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Dual Track
Clinical Trials NCT04098900
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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