FDA 510(k) Application Details - K121318

Device Classification Name	Reliner, Denture, Over The Counter   More FDA Info for this Device
510(K) Number	K121318
Device Name	Reliner, Denture, Over The Counter
Applicant	PERMA LABORATORIES 120 Wakefield Run Blvd Hinckley, OH 44233 US Other 510(k) Applications for this Company
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	05/02/2012
Decision Date	06/06/2012
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	Y
Expedited Review