FDA 510(k) Application Details - K210478

Device Classification Name

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510(K) Number K210478
Device Name 8mm Monopolar Curved Scissors
Applicant Iconocare Health
7825 East Redfield Rd.
Suite 103
Scottsdale, AZ 85260 US
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Contact Rick Ferreira
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Regulation Number

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Classification Product Code QSM
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Date Received 02/19/2021
Decision Date 09/30/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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