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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laparoscope, general & plastic surgery
510(k) Number K222575
Device Name HurriChem Device Kit
Applicant
ThermaSolutions LLC
1889 Buerkle Road
St. Paul,  MN  55110
Applicant Contact Gregg Giza
Correspondent
ThermaSolutions LLC
1889 Buerkle Road
St. Paul,  MN  55110
Correspondent Contact Rhea Johny
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received08/25/2022
Decision Date 12/06/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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