FDA 510(k) Application Details - K955535

Device Classification Name	Chamber, Hyperbaric   More FDA Info for this Device
510(K) Number	K955535
Device Name	Chamber, Hyperbaric
Applicant	LOUISVILLE LABORATORIES, INC. 2400 CRITTENDEN DR. LOUISVILLE, KY 40217-1865 US Other 510(k) Applications for this Company
Contact	DAVID PHELPS Other 510(k) Applications for this Contact
Regulation Number	868.5470   More FDA Info for this Regulation Number
Classification Product Code	CBF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/05/1995
Decision Date	07/01/1996
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