FDA 510(k) Application Details - K010659

Device Classification Name	Chamber, Hyperbaric   More FDA Info for this Device
510(K) Number	K010659
Device Name	Chamber, Hyperbaric
Applicant	SEA-LONG MEDICAL SYSTEMS, INC. 1983 SOUTH PARK RD. LOUISVILLE, KY 40219 US Other 510(k) Applications for this Company
Contact	GERALD COX 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	03/06/2001
Decision Date	05/16/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review