EMBOSPHERE MICROSPHERES


Device Classification Name

device, neurovascular embolization

510(k) Number K991549
Device Name EMBOSPHERE MICROSPHERES
Applicant
BIOSPHERE MEDICAL
1050 hingham st.
rockland, 
MA 
02370

Applicant Contact sheila hemeon-heyer
Correspondent
BIOSPHERE MEDICAL
1050 hingham st.
rockland, 
MA 
02370

Correspodent Contact sheila hemeon-heyer
Regulation Number 882.5950
Classification Product Code
HCG  
Date Received 05/03/1999
Decision Date 04/26/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No