BIOSORB RESORBABLE VOID FILLER


Device Classification Name

filler, bone void, calcium compound

510(k) Number K021963
Device Name BIOSORB RESORBABLE VOID FILLER
Original Applicant
SCIENCES ET BIO MATERIAUX (SBM)
zi du monge
lordes, 

FR

f 65100

Original Contact denis clement
Regulation Number 888.3045
Classification Product Code
MQV  
Date Received 06/14/2002
Decision Date 01/28/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No