GELSPHERES EMBOLIC AGENT


Device Classification Name

device, neurovascular embolization

510(k) Number K023089
Device Name GELSPHERES EMBOLIC AGENT
Original Applicant
BIOCURE, INC.
20310 sw 48th st.
ft. lauderdale, 
FL 
33332 -1111

Original Contact john greenbaum
Regulation Number 882.5950
Classification Product Code
HCG  
Subsequent Product Code
KRD  
Date Received 09/17/2002
Decision Date 12/16/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No