FDA 510(k) Application Details - K094041

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K094041
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant ALPHA ORTHOPAEDICS
23575 CABOT BLVD.
SUITE 210
HAYWARD, CA 94545 US
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Contact GINA TO
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 12/30/2009
Decision Date 04/07/2010
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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