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FDA 510(k) Application Details - K990680
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K990680
Device Name
Powered Laser Surgical Instrument
Applicant
DENTEK LASERSYSTEMS PRODUKTIONS GES.M.B.H.
GROTTENHOFSTRASSE 3
GRAZ A - 8053 AT
Other 510(k) Applications for this Company
Contact
DI WOLFGANG NINAUS
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
03/02/1999
Decision Date
07/30/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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