FDA 510(k) Application Details - K100543

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K100543
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant MEDISISS
2747 SW 6TH STREET
REDMOND, OR 97756 US
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Contact BRANDI JAMES
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 02/25/2010
Decision Date 07/23/2010
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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