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FDA 510(k) Application Details - K142614
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K142614
Device Name
Powered Laser Surgical Instrument
Applicant
AngioDynamics, Inc.
603 Queensbury Avenue
Queensbury, NY 12804 US
Other 510(k) Applications for this Company
Contact
Teri Juckett
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
GEX
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More FDA Info for this Product Code
Date Received
09/16/2014
Decision Date
10/10/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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