The following data is part of a premarket notification filed by Pillar Surgical, Inc. with the FDA for Pillar Nasal, Dorsal Columella And Nasal Dorsum Implants.
| Device ID | K992242 |
| 510k Number | K992242 |
| Device Name: | PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS |
| Classification | Prosthesis, Nose, Internal |
| Applicant | PILLAR SURGICAL, INC. P.O. BOX 8141 La Jolla, CA 92038 |
| Contact | Rpb Fritzenkotter |
| Correspondent | Rpb Fritzenkotter PILLAR SURGICAL, INC. P.O. BOX 8141 La Jolla, CA 92038 |
| Product Code | FZE |
| CFR Regulation Number | 878.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-02 |
| Decision Date | 1999-11-22 |
| Summary: | summary |