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FDA 510(k) Application Details - K970361
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K970361
Device Name
Powered Laser Surgical Instrument
Applicant
STEFANOVSKY & ASSOC.
30150 ROYALVIEW DR.
WILLOWICK, OH 44095 US
Other 510(k) Applications for this Company
Contact
DAVID W STEFANOVSKY
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
01/31/1997
Decision Date
03/18/1997
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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