FDA 510(k) Application Details - K220053

Device Classification Name Forceps, Biopsy, Electric

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510(K) Number K220053
Device Name Forceps, Biopsy, Electric
Applicant FUJIFILM Corporation
798 Miyanodai Kaisei-Machi
Ashigarakami-Gun 258-8538 JP
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Contact Randy Vader
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Regulation Number 876.4300

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Classification Product Code KGE
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Date Received 01/06/2022
Decision Date 02/04/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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