FDA 510(k) Application Details - K984640

Device Classification Name	Warmer, Blood, Non-Electromagnetic Radiation   More FDA Info for this Device
510(K) Number	K984640
Device Name	Warmer, Blood, Non-Electromagnetic Radiation
Applicant	ESTILL MEDICAL TECHNOLOGIES, INC. 17440 NORTH DALLAS PKWY.0 STE.100 DALLAS, TX 75287-7307 US Other 510(k) Applications for this Company
Contact	THOMAS KISTNER Other 510(k) Applications for this Contact
Regulation Number	864.9205   More FDA Info for this Regulation Number
Classification Product Code	BSB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/31/1998
Decision Date	07/01/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review