FDA 510(k) Application Details - K991029

Device Classification Name	Plate, Cranioplasty, Preformed, Non-Alterable   More FDA Info for this Device
510(K) Number	K991029
Device Name	Plate, Cranioplasty, Preformed, Non-Alterable
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	882.5330   More FDA Info for this Regulation Number
Classification Product Code	GXN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/29/1999
Decision Date	04/23/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review