FDA 510(k) Application Details - K973741

Device Classification Name	Warmer, Blood, Non-Electromagnetic Radiation   More FDA Info for this Device
510(K) Number	K973741
Device Name	Warmer, Blood, Non-Electromagnetic Radiation
Applicant	AUGUSTINE MEDICAL, INC. 10393 WEST 70TH ST. EDEN PRAIRIE, MN 55344 US Other 510(k) Applications for this Company
Contact	SCOTT D AUGUSTINE 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	10/01/1997
Decision Date	04/30/1998
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