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FDA 510(k) Application Details - K092197
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K092197
Device Name
Powered Laser Surgical Instrument
Applicant
BIOTEX, INC.
8058 EL RIO ST.
HOUSTON, TX 77054-4185 US
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ASHOK GOWDA
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
07/21/2009
Decision Date
10/06/2009
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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