FDA 510(k) Application Details - K091107

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K091107
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant HEMOSTATIX MEDICAL TECHNOLOGIES, LLC
8400 WOLF LAKE DR., STE. 109
BARTLETT, TN 38133 US
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Contact JEFF COBB
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 04/16/2009
Decision Date 05/01/2009
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 Y
Expedited Review



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