FDA 510(k) Application Details - K973417

Device Classification Name	Component, Cast   More FDA Info for this Device
510(K) Number	K973417
Device Name	Component, Cast
Applicant	CLINITEX MEDICAL CORP. 9801 KINCEY AVE., SUITE 100 HUNTERSVILLE, NC 28078 US Other 510(k) Applications for this Company
Contact	HOWELL H MICHAEL Other 510(k) Applications for this Contact
Regulation Number	888.5940   More FDA Info for this Regulation Number
Classification Product Code	LGF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/10/1997
Decision Date	12/09/1997
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