Device Classification Name |
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
|
510(k) Number |
K041523 |
Device Name |
XPS 3000 SYSTEM |
Applicant |
MEDTRONIC XOMED, INC. |
6743 SOUTHPOINT DR. NORTH |
JACKSONVILLE,
FL
32216
|
|
Applicant Contact |
MARTIN D SARGENT |
Correspondent |
MEDTRONIC XOMED, INC. |
6743 SOUTHPOINT DR. NORTH |
JACKSONVILLE,
FL
32216
|
|
Correspondent Contact |
MARTIN D SARGENT |
Regulation Number | 874.4250
|
Classification Product Code |
|
Date Received | 06/08/2004 |
Decision Date | 07/23/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|