IMBIBE II SYRINGE


Device Classification Name

syringe, piston

510(k) Number K030208
Device Name IMBIBE II SYRINGE
Original Applicant
ORTHOVITA, INC.
45 great valley pkwy.
malvern, 
PA 
19355

Original Contact andreina ide
Regulation Number 880.5860
Classification Product Code
FMF  
Date Received 01/21/2003
Decision Date 04/16/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No