FDA 510(k) Application Details - K012830

Device Classification Name	Orthosis, Cranial   More FDA Info for this Device
510(K) Number	K012830
Device Name	Orthosis, Cranial
Applicant	LERMAN & SON 8710 WILSHIRE BLVD. BEVERLY HILLS, CA 90211 US Other 510(k) Applications for this Company
Contact	MAX LERMAN Other 510(k) Applications for this Contact
Regulation Number	882.5970   More FDA Info for this Regulation Number
Classification Product Code	MVA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/23/2001
Decision Date	11/20/2001
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