BAXANO ULTRA LOW PROFILE RONGEUR


Device Classification Name

rongeur, manual

510(k) Number K080494
Device Name BAXANO ULTRA LOW PROFILE RONGEUR
Applicant
BAXANO, INC.
5582 chalon road
yorba linda, 
CA 
92886

Applicant Contact sharon rockwell
Correspondent
BAXANO, INC.
5582 chalon road
yorba linda, 
CA 
92886

Correspodent Contact sharon rockwell
Regulation Number 882.4840
Classification Product Code
HAE  
Date Received 02/22/2008
Decision Date 03/04/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No