FDA 510(k) Application Details - K972332

Device Classification Name	Plate, Cranioplasty, Preformed, Non-Alterable   More FDA Info for this Device
510(K) Number	K972332
Device Name	Plate, Cranioplasty, Preformed, Non-Alterable
Applicant	AESCULAP, INC. 1000 GATEWAY BLVD. SOUTH SAN FRANCISCO, CA 94080 US Other 510(k) Applications for this Company
Contact	MARY ELLEN HOLDEN 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	06/23/1997
Decision Date	01/16/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review