FDA 510(k) Application Details - K161953

Device Classification Name	More FDA Info for this Device
510(K) Number	K161953
Device Name	ReDe Mask
Applicant	TereoPneuma 13223 Black Mountain Rd., Ste 1-224 San Diego, CA 92129 US Other 510(k) Applications for this Company
Contact	Warren G. Young Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PRK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/18/2016
Decision Date	02/17/2017
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