PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA FOAM EMBOLIZATION PARTICLES


Device Classification Name

device, vascular, for promoting embolization

510(k) Number K073544
Device Name PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA FOAM EMBOLIZATION PARTICLES
Applicant
RJ MEDICAL, INC.
4921 robert j. mathews pkwy
#2
el dorado hills, 
CA 
95762

Applicant Contact jim innes
Correspondent
RJ MEDICAL, INC.
4921 robert j. mathews pkwy
#2
el dorado hills, 
CA 
95762

Correspodent Contact jim innes
Regulation Number 870.3300
Classification Product Code
KRD  
Date Received 12/18/2007
Decision Date 03/05/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No