FDA 510(k) Application Details - K014268

Device Classification Name	Neurosurgical Paddie   More FDA Info for this Device
510(K) Number	K014268
Device Name	Neurosurgical Paddie
Applicant	PERLEI MEDICAL, INC. 962 ALLEGRO LN. APOLLO BEACH, FL 33572 US Other 510(k) Applications for this Company
Contact	ART WARD Other 510(k) Applications for this Contact
Regulation Number	882.4700   More FDA Info for this Regulation Number
Classification Product Code	HBA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/27/2001
Decision Date	03/27/2002
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