FDA 510(k) Application Details - K973818

Device Classification Name	Device, Biopsy, Endomyocardial   More FDA Info for this Device
510(K) Number	K973818
Device Name	Device, Biopsy, Endomyocardial
Applicant	BOSTON SCIENTIFIC CORP. 17425 NORTH EAST UNION HILL RD NORTHWEST TECHNOLOGY CENTER REDMOND, WA 98052-3376 US Other 510(k) Applications for this Company
Contact	JOCELYN KERSTEN Other 510(k) Applications for this Contact
Regulation Number	870.4075   More FDA Info for this Regulation Number
Classification Product Code	DWZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/07/1997
Decision Date	12/16/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review