| Device Classification Name |
Awl
|
|---|
| 510(k) Number |
K875223 |
|---|
| Device Name |
DANNINGER ORTHOPAEDIC AWL |
|---|
| Applicant |
| DANNINGER MEDICAL TECHNOLOGY, INC. |
| C/O BUCKMAN CO., INC. |
| 1000 BURNETT AVENUE, SUITE 250 |
|
CONCORD,
CA
94520
|
|
| Applicant Contact |
DAVID SCHLERF |
| Correspondent |
| DANNINGER MEDICAL TECHNOLOGY, INC. |
| C/O BUCKMAN CO., INC. |
| 1000 BURNETT AVENUE, SUITE 250 |
|
CONCORD,
CA
94520
|
|
| Correspondent Contact |
DAVID SCHLERF |
| Regulation Number | 888.4540
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 12/22/1987 |
|---|
| Decision Date | 02/17/1988 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Orthopedic
|
|---|
| 510k Review Panel |
Orthopedic
|
|---|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|