FDA 510(k) Application Details - K082455

Device Classification Name	Chamber, Hyperbaric   More FDA Info for this Device
510(K) Number	K082455
Device Name	Chamber, Hyperbaric
Applicant	GULF COAST HYPERBARICS, INC. 1100 WEST 26TH ST. LYNN HAVEN, FL 32444 US Other 510(k) Applications for this Company
Contact	JAMES W MCCARTHY 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	08/26/2008
Decision Date	05/22/2009
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