The following data is part of a premarket notification filed by Aesthetic And Reconstructive Technologies, Inc. with the FDA for Aart Malar Implant.
| Device ID | K021419 |
| 510k Number | K021419 |
| Device Name: | AART MALAR IMPLANT |
| Classification | Implant, Malar |
| 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 | LZK |
| CFR Regulation Number | 878.3550 [🔎] |
| 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 |
|---|---|---|
| B490401202A0 | K021419 | 000 |
| B4904011035A0 | K021419 | 000 |
| B49040110352A0 | K021419 | 000 |
| B490401102A0 | K021419 | 000 |
| B4904011026B0 | K021419 | 000 |
| B4904011026A0 | K021419 | 000 |
| B49040110262A0 | K021419 | 000 |
| B4904011025B0 | K021419 | 000 |
| B4904011025A0 | K021419 | 000 |
| B49040110252A0 | K021419 | 000 |
| B490401101A0 | K021419 | 000 |
| B4904011016B0 | K021419 | 000 |
| B4904011016A0 | K021419 | 000 |
| B49040110162A0 | K021419 | 000 |
| B4904011015B0 | K021419 | 000 |
| B4904011015A0 | K021419 | 000 |
| B4904011035B0 | K021419 | 000 |
| B49040110362A0 | K021419 | 000 |
| B4904011036A0 | K021419 | 000 |
| B4904012026B0 | K021419 | 000 |
| B4904012026A0 | K021419 | 000 |
| B49040120262A0 | K021419 | 000 |
| B4904012025B0 | K021419 | 000 |
| B4904012025A0 | K021419 | 000 |
| B49040120252A0 | K021419 | 000 |
| B490401201A0 | K021419 | 000 |
| B4904012016B0 | K021419 | 000 |
| B4904012016A0 | K021419 | 000 |
| B49040120162A0 | K021419 | 000 |
| B4904012015B0 | K021419 | 000 |
| B4904012015A0 | K021419 | 000 |
| B49040120152A0 | K021419 | 000 |
| B490401103A0 | K021419 | 000 |
| B4904011036B0 | K021419 | 000 |
| B49040110152A0 | K021419 | 000 |