FDA 510(k) Application Details - K021397

Device Classification Name	Agents,Embolic,For Treatment Of Uterine Fibroids   More FDA Info for this Device
510(K) Number	K021397
Device Name	Agents,Embolic,For Treatment Of Uterine Fibroids
Applicant	BIOSPHERE MEDICAL, INC. 49 PLAIN ST. NORTH ATTLEBORO, MA 02760 US Other 510(k) Applications for this Company
Contact	SHIELA HEMEON-HEYER Other 510(k) Applications for this Contact
Regulation Number	870.3300   More FDA Info for this Regulation Number
Classification Product Code	NAJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/02/2002
Decision Date	11/22/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review