FDA 510(k) Application Details - K172672

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K172672
Device Name Laparoscope, General & Plastic Surgery
Applicant Micromedics Inc. (d/b/a Nordson Medical)
1270 Eagan Industrial Road, Suite 120
St.Paul, MN 55121 US
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Contact Kristi Brezinka
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 09/05/2017
Decision Date 10/06/2017
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



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