THE ONCONTROL BONE ACCESS SYSTEM BY VIDACARE


Device Classification Name

instrument, biopsy

510(k) Number K112468
Device Name THE ONCONTROL BONE ACCESS SYSTEM BY VIDACARE
Applicant
REGULATORY SPECIALISTS, INC.
3722 ave sausalito
irvine, 
CA 
92606

Applicant Contact grace holland
Correspondent
REGULATORY SPECIALISTS, INC.
3722 ave sausalito
irvine, 
CA 
92606

Correspodent Contact grace holland
Regulation Number 876.1075
Classification Product Code
KNW  
Subsequent Product Code
OAR  
Date Received 08/26/2011
Decision Date 10/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No