FRAMELOCK; FRAMELOCK ACCESSORIES


Device Classification Name

drills, burrs, trephines & accessories (manual)

510(k) Number K022370
Device Name FRAMELOCK; FRAMELOCK ACCESSORIES
Original Applicant
MEDTRONIC XOMED, INC.
6743 southpoint dr. north
jacksonville, 
FL 
32216

Original Contact b.l. mcdermott
Regulation Number 882.4300
Classification Product Code
HBG  
Date Received 07/22/2002
Decision Date 10/18/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No