FDA 510(k) Application Details - K043377

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K043377
Device Name	Powered Laser Surgical Instrument
Applicant	TYRELL, INC. 2202 TIMBERLOCH PLACE SUITE 230 THE WOODLANDS, TX 77380 US Other 510(k) Applications for this Company
Contact	DARLA J ELKIN 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	12/08/2004
Decision Date	06/01/2005
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