Device Classification Name |
drill, surgical, ent (electric or pneumatic) including handpiece
|
510(k) Number |
K945659 |
Device Name |
BLACKSTAR(TM) STAR SYSTEM |
Applicant |
XOMED-TREACE, INC. |
6743 SOUTHPOINT DRIVE NORTH |
JACKSONVILLE,
FL
32216 -0980
|
|
Correspondent |
XOMED-TREACE, INC. |
6743 SOUTHPOINT DRIVE NORTH |
JACKSONVILLE,
FL
32216 -0980
|
|
Regulation Number | 874.4250
|
Classification Product Code |
|
Date Received | 11/17/1994 |
Decision Date | 01/09/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|