FDA 510(k) Application Details - K955483

Device Classification Name	Mask, Oxygen, Low Concentration, Venturi   More FDA Info for this Device
510(K) Number	K955483
Device Name	Mask, Oxygen, Low Concentration, Venturi
Applicant	HOSPITAK, INC. 10 DANIEL ST. FARMINGDALE, NY 11735 US Other 510(k) Applications for this Company
Contact	WILLIAM LACEY Other 510(k) Applications for this Contact
Regulation Number	868.5600   More FDA Info for this Regulation Number
Classification Product Code	BYF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/01/1995
Decision Date	02/28/1996
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