FDA 510(k) Application Details - K080622

Device Classification Name	Nasopharyngoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K080622
Device Name	Nasopharyngoscope (Flexible Or Rigid)
Applicant	OPTIM, INC. 64 TECHNOLOGY PARK RD. STURBRIDGE, MA 01566-1262 US Other 510(k) Applications for this Company
Contact	ROBERT KRUPA Other 510(k) Applications for this Contact
Regulation Number	874.4760   More FDA Info for this Regulation Number
Classification Product Code	EOB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/05/2008
Decision Date	04/02/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review