FDA 510(k) Application Details - K991486

Device Classification Name	Device, Biopsy, Endomyocardial   More FDA Info for this Device
510(K) Number	K991486
Device Name	Device, Biopsy, Endomyocardial
Applicant	MEDCANICA, INC. 19526 EAST LAKE DR. MIAMI, FL 33015 US Other 510(k) Applications for this Company
Contact	AL WEISENBORN 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	04/28/1999
Decision Date	11/05/1999
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