FDA 510(k) Application Details - K161600

Device Classification Name Electrode, Electrosurgical

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510(K) Number K161600
Device Name Electrode, Electrosurgical
Applicant OLYMPUS WINTER & IBE GMBH
KUEHNSTRASSE 61
Hamburg 22045 DE
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Contact Katharina Campbell
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Regulation Number 878.4400

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Classification Product Code JOS
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Date Received 06/09/2016
Decision Date 09/06/2016
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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