FDA 510(k) Application Details - K972322

Device Classification Name	Plate, Bone   More FDA Info for this Device
510(K) Number	K972322
Device Name	Plate, Bone
Applicant	WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. JACKSONVILLE, FL 32218 US Other 510(k) Applications for this Company
Contact	DIANA PRESTON Other 510(k) Applications for this Contact
Regulation Number	872.4760   More FDA Info for this Regulation Number
Classification Product Code	JEY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/20/1997
Decision Date	08/18/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review