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FDA 510(k) Application Details - K082956
Device Classification Name
Electrosurgical, Cutting & Coagulation & Accessories
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510(K) Number
K082956
Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Applicant
ALPHA ORTHOPAEDICS
23575 CABOT BLVD., STE. 2
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
10/03/2008
Decision Date
12/18/2008
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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