FDA 510(k) Application Details - K200609

Device Classification Name	Nasopharyngoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K200609
Device Name	Nasopharyngoscope (Flexible Or Rigid)
Applicant	Optim, LLC 64 Technology Park Rd. Sturbridge, MA 01566 US Other 510(k) Applications for this Company
Contact	Jenna Lipka 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	03/09/2020
Decision Date	01/13/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review