FDA 510(k) Application Details - K083840

Device Classification Name Endoscope, Rigid

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510(K) Number K083840
Device Name Endoscope, Rigid
Applicant MSI MEDSERV INTERNATIONAL DEUTSCHLAND GMBH
ESCAD-STR 3
PFULLENDORF D-88630 DE
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Contact CHRISTINE STROBEL
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Regulation Number 876.1500

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Classification Product Code GCM
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Date Received 12/24/2008
Decision Date 09/28/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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