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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Surgical, Computer Controlled Instrument, Remanufactured
510(k) Number K242610
Device Name 8mm Monopolar Curved Scissors (470179)
Applicant
Iconocare Health
7825 E. Redfield Rd.
Suite 103
Scottsdale,  AZ  85260
Applicant Contact Rick Ferreira
Correspondent
Iconocare Health
7825 E. Redfield Rd.
Suite 103
Scottsdale,  AZ  85260
Correspondent Contact Rick Ferreira
Regulation Number876.1500
Classification Product Code
QSM  
Date Received09/03/2024
Decision Date 03/11/2025
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
Predetermined Change
Control Plan Authorized		 No
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