The following data is part of a premarket notification filed by Aesthetic And Reconstructive Technologies, Inc. with the FDA for Aart Nasal Implant.
| Device ID | K021418 |
| 510k Number | K021418 |
| Device Name: | AART NASAL IMPLANT |
| Classification | Prosthesis, Nose, Internal |
| Applicant | AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. 3545 AIRWAY DR. SUITE 108 Reno, NV 89511 |
| Contact | Catherine Riple |
| Correspondent | Catherine Riple AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. 3545 AIRWAY DR. SUITE 108 Reno, NV 89511 |
| Product Code | FZE |
| CFR Regulation Number | 878.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-03 |
| Decision Date | 2002-07-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B490402505B0 | K021418 | 000 |
| B490402101B0 | K021418 | 000 |
| B4904022022A0 | K021418 | 000 |
| B490402202B0 | K021418 | 000 |
| B4904023032A0 | K021418 | 000 |
| B490402303A0 | K021418 | 000 |
| B490402303B0 | K021418 | 000 |
| B4904024042A0 | K021418 | 000 |
| B490402404A0 | K021418 | 000 |
| B490402404B0 | K021418 | 000 |
| B4904025052A0 | K021418 | 000 |
| B490402505A0 | K021418 | 000 |
| B4904021012A0 | K021418 | 000 |