| Device Classification Name |
Pin, Fixation, Smooth
|
| 510(k) Number |
K960642 |
| Device Name |
NANCY NAIL |
| Applicant |
| Landos, Inc. |
| 100 Lindenwood Dr. |
|
Malvern,
PA
19355
|
|
| Applicant Contact |
JEAN-PAUL BURTIN |
| Correspondent |
| Landos, Inc. |
| 100 Lindenwood Dr. |
|
Malvern,
PA
19355
|
|
| Correspondent Contact |
JEAN-PAUL BURTIN |
| Regulation Number | 888.3040 |
| Classification Product Code |
|
| Date Received | 02/14/1996 |
| Decision Date | 05/17/1996 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Orthopedic
|
| 510k Review Panel |
Orthopedic
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|