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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Gastrointestinal Motility (Electrical)
510(k) Number K240007
Device Name Solar Compact (G4-1)
Applicant
Laborie Medical Technologies, Corp.
180 International Dr.
Portsmouth,  NH  03801
Applicant Contact Ingrid Dirtzu
Correspondent
Laborie Medical Technologies, Corp.
180 International Dr.
Portsmouth,  NH  03801
Correspondent Contact Ingrid Dirtzu
Regulation Number876.1725
Classification Product Code
FFX  
Date Received01/02/2024
Decision Date 05/06/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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