| Device Classification Name |
Prosthesis, Nose, Internal
|
| 510(k) Number |
K992242 |
| Device Name |
PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS |
| Applicant |
| Pillar Surgical, Inc. |
| P.O. Box 8141 |
|
La Jolla,
CA
92038
|
|
| Applicant Contact |
RPB FRITZENKOTTER |
| Correspondent |
| Pillar Surgical, Inc. |
| P.O. Box 8141 |
|
La Jolla,
CA
92038
|
|
| Correspondent Contact |
RPB FRITZENKOTTER |
| Regulation Number | 878.3680 |
| Classification Product Code |
|
| Date Received | 07/02/1999 |
| Decision Date | 11/22/1999 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General & Plastic Surgery
|
| 510k Review Panel |
General & Plastic Surgery
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|