FDA 510(k) Application Details - K970046

Device Classification Name	Mask, Scavenging   More FDA Info for this Device
510(K) Number	K970046
Device Name	Mask, Scavenging
Applicant	ACCUTRON, INC. 2020 WEST MELINDA LN. PHOENIX, AZ 85027 US Other 510(k) Applications for this Company
Contact	JAMES R MOORE Other 510(k) Applications for this Contact
Regulation Number	868.5590   More FDA Info for this Regulation Number
Classification Product Code	KHA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/06/1997
Decision Date	03/28/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review