FDA 510(k) Application Details - K093108

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K093108
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant Stryker Leibinger GmbH & Co. KG
750 TRADE CENTRE WAY
SUITE 200
PORTAGE, MI 49002 US
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Contact ROB YAMASHITA
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 10/01/2009
Decision Date 06/22/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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