FDA 510(k) Application Details - K241739

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K241739
Device Name Laparoscope, General & Plastic Surgery
Applicant Micromedics, Inc.
7125 Northland Terrace North
Suite 200
Minneapolis, MN 55116 US
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Contact Joel DeLaTorre
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 06/17/2024
Decision Date 07/15/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review

FDA Source Information for K241739


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