FDA 510(k) Application Details - K163412

Device Classification Name	Laryngoscope, Rigid   More FDA Info for this Device
510(K) Number	K163412
Device Name	Laryngoscope, Rigid
Applicant	Girgis Scope LLC 2 Stonegate Drive Monroe Township, NJ 08831 US Other 510(k) Applications for this Company
Contact	Madgy S. Girgis Other 510(k) Applications for this Contact
Regulation Number	868.5540   More FDA Info for this Regulation Number
Classification Product Code	CCW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/05/2016
Decision Date	06/22/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review