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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Esophageal Motility, Anorectal Motility, And Tube
510(k) Number K234107
Device Name Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)
Applicant
Laborie Medical Technologies, Corp.
180 International Dr.
Portsmouth,  NH  03801
Applicant Contact Arpit Sisodiya
Correspondent
Laborie Medical Technologies, Corp.
180 International Dr.
Portsmouth,  NH  03801
Correspondent Contact Arpit Sisodiya
Regulation Number876.1725
Classification Product Code
KLA  
Date Received12/26/2023
Decision Date 04/23/2024
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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