NAVIOPFS


Device Classification Name

orthopedic stereotaxic instrument

510(k) Number K121936
Device Name NAVIOPFS
Applicant
BLUE BELT TECHNOLOGIES, INC.
2828 liberty avenue
suite 100
pittsburgh, 
PA 
15222

Applicant Contact richard g confer
Correspondent
BLUE BELT TECHNOLOGIES, INC.
2828 liberty avenue
suite 100
pittsburgh, 
PA 
15222

Correspodent Contact richard g confer
Regulation Number 882.4560
Classification Product Code
OLO  
Date Received 07/02/2012
Decision Date 11/30/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No