FDA 510(k) Application Details - K974406

Device Classification Name	Template   More FDA Info for this Device
510(K) Number	K974406
Device Name	Template
Applicant	ORTHO-GRAPHICS, INC. 100 NORTH MEDICAL DRIVE # 4550 SALTLAKE, UT 84113 US Other 510(k) Applications for this Company
Contact	PETER M STEVENS Other 510(k) Applications for this Contact
Regulation Number	888.4800   More FDA Info for this Regulation Number
Classification Product Code	HWT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/21/1997
Decision Date	02/18/1998
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