Device Classification Name |
Orthopedic Manual Surgical Instrument
|
510(k) Number |
K933242 |
Device Name |
SOFAMOR ORTHOPAEDIC INSTRUMENTS |
Applicant |
DANEK MEDICAL, INC. |
3092 DIRECTOR'S ROW |
MEMPHIS,
TN
38131
|
|
Applicant Contact |
BRIAN GOODEN |
Correspondent |
DANEK MEDICAL, INC. |
3092 DIRECTOR'S ROW |
MEMPHIS,
TN
38131
|
|
Correspondent Contact |
BRIAN GOODEN |
Regulation Number | 888.4540
|
Classification Product Code |
|
Date Received | 07/02/1993 |
Decision Date | 01/28/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|