FDA 510(k) Application Details - K964377

Device Classification Name	System, Thermal Regulating   More FDA Info for this Device
510(K) Number	K964377
Device Name	System, Thermal Regulating
Applicant	GIBECK, INC. 10640 EAST 59TH ST. P.O. BOX 36430 INDIANAPOLIS, IN 46236 US Other 510(k) Applications for this Company
Contact	ELAINE M HEAZELTINE Other 510(k) Applications for this Contact
Regulation Number	870.5900   More FDA Info for this Regulation Number
Classification Product Code	DWJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/01/1996
Decision Date	04/23/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review