FDA 510(k) Application Details - K003630

Device Classification Name	Orthosis, Cranial   More FDA Info for this Device
510(K) Number	K003630
Device Name	Orthosis, Cranial
Applicant	DANMAR PRODUCTS, INC. 221 JACKSON INDUSTRIAL DR. ANN ARBOR, MI 48103 US Other 510(k) Applications for this Company
Contact	KAREN A LINDNER 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	11/24/2000
Decision Date	05/29/2001
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