FDA 510(k) Application Details - K222783

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K222783
Device Name Laparoscope, General & Plastic Surgery
Applicant LSI Solutions, Inc.
7796 Victor-Mendon Rd
Victor, NY 14564 US
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Contact Christopher B Miller
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 09/15/2022
Decision Date 01/12/2024
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

FDA Source Information for K222783


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