Device Classification Name |
Drills, Burrs, Trephines & Accessories (Manual)
|
510(k) Number |
K022370 |
Device Name |
FRAMELOCK; FRAMELOCK ACCESSORIES |
Applicant |
MEDTRONIC XOMED, INC. |
6743 SOUTHPOINT DR. NORTH |
JACKSONVILLE,
FL
32216
|
|
Applicant Contact |
B.L. MCDERMOTT |
Correspondent |
MEDTRONIC XOMED, INC. |
6743 SOUTHPOINT DR. NORTH |
JACKSONVILLE,
FL
32216
|
|
Correspondent Contact |
B.L. MCDERMOTT |
Regulation Number | 882.4300
|
Classification Product Code |
|
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
|
|
|