The following data is part of a premarket notification filed by Aesthetic And Reconstructive Technologies, Inc. with the FDA for Aart Gluteal Implant.
| Device ID | K021839 |
| 510k Number | K021839 |
| Device Name: | AART GLUTEAL IMPLANT |
| Classification | Elastomer, Silicone Block |
| Applicant | AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. 5871 LONE PINE PLACE Paso Robles, CA 93446 |
| Contact | Catherine Riple |
| Correspondent | Catherine Riple AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. 5871 LONE PINE PLACE Paso Robles, CA 93446 |
| Product Code | MIB |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-04 |
| Decision Date | 2002-07-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B4905013039A0 | K021839 | 000 |
| B4905012062C0 | K021839 | 000 |
| B490501205B0 | K021839 | 000 |
| B4905012059B0 | K021839 | 000 |
| B4905012052C0 | K021839 | 000 |
| B490501204B0 | K021839 | 000 |
| B4905012049A0 | K021839 | 000 |
| B4905012042C0 | K021839 | 000 |
| B490501203B0 | K021839 | 000 |
| B4905012039A0 | K021839 | 000 |
| B4905012067A0 | K021839 | 000 |
| B490501206B0 | K021839 | 000 |
| B4905013002C0 | K021839 | 000 |
| B4905013037A0 | K021839 | 000 |
| B4905013033A0 | K021839 | 000 |
| B4905013032C0 | K021839 | 000 |
| B490501302B0 | K021839 | 000 |
| B4905013029A0 | K021839 | 000 |
| B4905013022C0 | K021839 | 000 |
| B490501301B0 | K021839 | 000 |
| B4905013012C0 | K021839 | 000 |
| B490501300B0 | K021839 | 000 |
| B4905012032C0 | K021839 | 000 |
| B490501202B0 | K021839 | 000 |
| B4905011042B0 | K021839 | 000 |
| B490501103B0 | K021839 | 000 |
| B4905011039A0 | K021839 | 000 |
| B4905011032C0 | K021839 | 000 |
| B490501102B0 | K021839 | 000 |
| B4905011022C0 | K021839 | 000 |
| B490501101B0 | K021839 | 000 |
| B4905011012C0 | K021839 | 000 |
| B4905011012B0 | K021839 | 000 |
| B4905011042C0 | K021839 | 000 |
| B490501104B0 | K021839 | 000 |
| B4905011051A0 | K021839 | 000 |
| B4905012022C0 | K021839 | 000 |
| B490501201B0 | K021839 | 000 |
| B4905012012C0 | K021839 | 000 |
| B490501106C0 | K021839 | 000 |
| B4905011069A0 | K021839 | 000 |
| B4905011062C0 | K021839 | 000 |
| B4905011061A0 | K021839 | 000 |
| B490501105B0 | K021839 | 000 |
| B4905011052C0 | K021839 | 000 |
| B49050020062B0 | K021839 | 000 |
| B490501303B0 | K021839 | 000 |
| B490600803B0 | K021839 | 000 |
| B4905016047A0 | K021839 | 000 |
| B4905016042B0 | K021839 | 000 |
| B4905016042A0 | K021839 | 000 |
| B490501603B0 | K021839 | 000 |
| B4905016039A0 | K021839 | 000 |
| B4905016037A0 | K021839 | 000 |
| B4905016032C0 | K021839 | 000 |
| B490501602B0 | K021839 | 000 |
| B4905016027A0 | K021839 | 000 |
| B490501604B0 | K021839 | 000 |
| B49060070155108B0 | K021839 | 000 |
| B49060070155208B0 | K021839 | 000 |
| B4906008032C0 | K021839 | 000 |
| B4906008032B0 | K021839 | 000 |
| B4906008022C0 | K021839 | 000 |
| B4906008022B0 | K021839 | 000 |
| B4906008012B0 | K021839 | 000 |
| B49060070355308B0 | K021839 | 000 |
| B49060070255308B0 | K021839 | 000 |
| B49060070255108B0 | K021839 | 000 |
| B49060070155308B0 | K021839 | 000 |
| B4905016022C0 | K021839 | 000 |
| B490501601B0 | K021839 | 000 |
| B490501307B0 | K021839 | 000 |
| B4905013072C0 | K021839 | 000 |
| B490501306B0 | K021839 | 000 |
| B4905013069A0 | K021839 | 000 |
| B4905013062C0 | K021839 | 000 |
| B490501305B0 | K021839 | 000 |
| B4905013052C0 | K021839 | 000 |
| B490501304B0 | K021839 | 000 |
| B4905013049A0 | K021839 | 000 |
| B4905013082B0 | K021839 | 000 |
| B4905013083A0 | K021839 | 000 |
| B490501308A0 | K021839 | 000 |
| B4905016017A0 | K021839 | 000 |
| B4905016012C0 | K021839 | 000 |
| B490501310A0 | K021839 | 000 |
| B4905013109A0 | K021839 | 000 |
| B4905013103A0 | K021839 | 000 |
| B4905013102A0 | K021839 | 000 |
| B490501309A0 | K021839 | 000 |
| B4905013099A0 | K021839 | 000 |
| B4905013092A0 | K021839 | 000 |
| B4905013042C0 | K021839 | 000 |