FDA 510(k) Application Details - K963326

Device Classification Name	Dilator, Nasal   More FDA Info for this Device
510(K) Number	K963326
Device Name	Dilator, Nasal
Applicant	CAMBRIDGE ASSOC. 15 OAK ST. BEVERLY FARMS, MA 01915 US Other 510(k) Applications for this Company
Contact	FRAN WHITE Other 510(k) Applications for this Contact
Regulation Number	874.3900   More FDA Info for this Regulation Number
Classification Product Code	LWF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/23/1996
Decision Date	02/12/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review