FDA 510(k) Application Details - K970642

Device Classification Name	Arthroscope   More FDA Info for this Device
510(K) Number	K970642
Device Name	Arthroscope
Applicant	LUXTEC CORP. 45 PONTIAC RD. NEWTON, MA 02168 US Other 510(k) Applications for this Company
Contact	JOSEPH RESS Other 510(k) Applications for this Contact
Regulation Number	888.1100   More FDA Info for this Regulation Number
Classification Product Code	HRX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/20/1997
Decision Date	05/21/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review