FDA 510(k) Application Details - K101771

Device Classification Name	Reliner, Denture, Over The Counter   More FDA Info for this Device
510(K) Number	K101771
Device Name	Reliner, Denture, Over The Counter
Applicant	MAJESTIC DRUG CO., INC. 848-1/2 DERBY AVENUE ORANGE, CT 06477 US Other 510(k) Applications for this Company
Contact	ROGER S MASTRONY Other 510(k) Applications for this Contact
Regulation Number	872.3560   More FDA Info for this Regulation Number
Classification Product Code	EBP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/24/2010
Decision Date	09/20/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review