FDA 510(k) Application Details - K972175

Device Classification Name	More FDA Info for this Device
510(K) Number	K972175
Device Name	INFUSASLEEVE IIA (IS-2A)
Applicant	LOCALMED, INC. 1820 EMBARCADERO RD. PALO ALTO, CA 94303 US Other 510(k) Applications for this Company
Contact	EDWIN L EE Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/09/1997
Decision Date	08/28/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review