FDA 510(k) Application Details - K981546

Device Classification Name	Mouthguard, Prescription   More FDA Info for this Device
510(K) Number	K981546
Device Name	Mouthguard, Prescription
Applicant	HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD. SOUTH BEND, IN 46614-2517 US Other 510(k) Applications for this Company
Contact	CHERYL V ZIMMERMAN Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MQC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/30/1998
Decision Date	07/15/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review