EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION


Device Classification Name

agents,embolic,for treatment of uterine fibroids

510(k) Number K021397
Device Name EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION
Original Applicant
BIOSPHERE MEDICAL, INC.
49 plain st.
north attleboro, 
MA 
02760

Original Contact shiela hemeon-heyer
Regulation Number 870.3300
Classification Product Code
NAJ  
Date Received 05/02/2002
Decision Date 11/22/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No