FDA 510(k) Application Details - K970785

Device Classification Name	Resuscitator,Manual,Non Self-Inflating   More FDA Info for this Device
510(K) Number	K970785
Device Name	Resuscitator,Manual,Non Self-Inflating
Applicant	SIMS 5100 TICE ST. FT. MYERS, FL 33905 US Other 510(k) Applications for this Company
Contact	AVIA TONEY Other 510(k) Applications for this Contact
Regulation Number	868.5905   More FDA Info for this Regulation Number
Classification Product Code	NHK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/04/1997
Decision Date	06/13/1997
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