FDA 510(k) Application Details - K982241

Device Classification Name	Apparatus, Autotransfusion   More FDA Info for this Device
510(K) Number	K982241
Device Name	Apparatus, Autotransfusion
Applicant	DUXBURY SCIENTIFIC INC. 80 SEABURY POINT RD. DUXBURY, MA 02332 US Other 510(k) Applications for this Company
Contact	ROBERT M ENGLER Other 510(k) Applications for this Contact
Regulation Number	868.5830   More FDA Info for this Regulation Number
Classification Product Code	CAC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/25/1998
Decision Date	11/30/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review