FDA 510(k) Application Details - K980734

Device Classification Name	Arthroscope   More FDA Info for this Device
510(K) Number	K980734
Device Name	Arthroscope
Applicant	MYELOTEC, INC. 4000 NORTHFIELD WAY, SUITE 900 ROSWELL, GA 30076 US Other 510(k) Applications for this Company
Contact	THOMAS A DUNKLE 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	02/25/1998
Decision Date	08/11/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review