FDA 510(k) Application Details - K962400

Device Classification Name	Dilator, Nasal   More FDA Info for this Device
510(K) Number	K962400
Device Name	Dilator, Nasal
Applicant	AMERICAN WHITE CROSS, INC. 349 LAKE RD. P.O. BOX 419 DAYVILLE, CT 06241 US Other 510(k) Applications for this Company
Contact	PAUL B CALLAHAN 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	06/21/1996
Decision Date	09/09/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review