FDA 510(k) Application Details - K962807

Device Classification Name	Neurosurgical Paddie   More FDA Info for this Device
510(K) Number	K962807
Device Name	Neurosurgical Paddie
Applicant	AMERICAN SURGICAL SPONGES 55 NORTHERN BLVD. GREAT NECK, NY 11021 US Other 510(k) Applications for this Company
Contact	CAROLANN KOTULA 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	07/18/1996
Decision Date	05/02/1997
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