FDA 510(k) Application Details - K971297

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K971297
Device Name	Plate, Fixation, Bone
Applicant	KLS-MARTIN L.P. 11239-1 ST. JOHN'S IND. PKWY. SOUTH JACKSONVILLE, FL 32246 US Other 510(k) Applications for this Company
Contact	MIKE GREENE Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	HRS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/08/1997
Decision Date	05/08/1997
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