K992242 is an FDA 510(k) clearance for the PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS, a Prosthesis, Nose, Internal (Class II — Special Controls, product code FZE), submitted by Pillar Surgical, Inc. (La Jolla, US). The FDA issued a Cleared decision on November 22, 1999, 143 days after receiving the submission on July 2, 1999. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3680.
| 510(k) Number | K992242 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 02, 1999 |
| Decision Date | November 22, 1999 |
| Days to Decision | 143 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FZE — Prosthesis, Nose, Internal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.3680 |