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FDA 510(k) Application Details - K110189
Device Classification Name
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
More FDA Info for this Device
510(K) Number
K110189
Device Name
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Applicant
ASCENT HEALTHCARE SOLUTIONS
10232 SOUTH 51ST STREET
PHOENIX, AZ 85044 US
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Contact
AMANDA BABCOCK
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Regulation Number
878.4400
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Classification Product Code
NUJ
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More FDA Info for this Product Code
Date Received
01/24/2011
Decision Date
07/18/2011
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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