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FDA 510(k) Application Details - K062363
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K062363
Device Name
Powered Laser Surgical Instrument
Applicant
B&W TEK, INC.
19 SHEA WAY, SUITE 301
NEWARK, DE 19713 US
Other 510(k) Applications for this Company
Contact
SEAN WANG
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
GEX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/10/2006
Decision Date
01/17/2007
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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