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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tubes, gastrointestinal (and accessories)
510(k) Number K230131
Device Name ReShape Calibration Tubes
Applicant
ReShape Lifesciences
1001 Calle Amanecer
San Clemente,  CA  92673
Applicant Contact Dov Gal
Correspondent
ReShape Lifesciences
1001 Calle Amanecer
San Clemente,  CA  92673
Correspondent Contact Dov Gal
Regulation Number876.5980
Classification Product Code
KNT  
Date Received01/17/2023
Decision Date 02/15/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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