FDA 510(k) Application Details - K094009

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K094009
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant HALT MEDICAL INC
131 SAND CREEK RD STE., B
BRENTWOOD, CA 94513 US
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Contact RUSS DELONZOR
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 12/28/2009
Decision Date 06/14/2010
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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