The following data is part of a premarket notification filed by Aesthetic And Reconstructive Technologies, Inc. with the FDA for Aart Pectoralis Implant.
| Device ID | K021337 |
| 510k Number | K021337 |
| Device Name: | AART PECTORALIS IMPLANT |
| Classification | Implant, Muscle, Pectoralis |
| 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 | MIC |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-26 |
| Decision Date | 2002-07-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B49050010552B0 | K021337 | 000 |
| B49050010252C0 | K021337 | 000 |
| B4905001016C0 | K021337 | 000 |
| B49050010162D0 | K021337 | 000 |
| B49050010162C0 | K021337 | 000 |
| B4905001015C0 | K021337 | 000 |
| B49050010152D0 | K021337 | 000 |
| B49050010152C0 | K021337 | 000 |
| B49050020153 | K021337 | 000 |
| B4905002015 | K021337 | 000 |
| B49050020063 | K021337 | 000 |
| B4905002006 | K021337 | 000 |
| B49050020053 | K021337 | 000 |
| B49050010252D0 | K021337 | 000 |
| B4905001025C0 | K021337 | 000 |
| B49050010262D0 | K021337 | 000 |
| B49050010552A0 | K021337 | 000 |
| B4905001046A0 | K021337 | 000 |
| B49050010462B0 | K021337 | 000 |
| B49050010462A0 | K021337 | 000 |
| B4905001045A0 | K021337 | 000 |
| B49050010452B0 | K021337 | 000 |
| B49050010452A0 | K021337 | 000 |
| B4905001036C0 | K021337 | 000 |
| B49050010362D0 | K021337 | 000 |
| B4905001035C0 | K021337 | 000 |
| B49050010352D0 | K021337 | 000 |
| B4905001026C0 | K021337 | 000 |
| B4905002005 | K021337 | 000 |
| B4905001066 | K021337 | 000 |
| B4905001065 | K021337 | 000 |
| B4905004025 | K021337 | 000 |
| B4905004016 | K021337 | 000 |
| B4905004015 | K021337 | 000 |
| B4905003026 | K021337 | 000 |
| B4905003025 | K021337 | 000 |
| B4905003016 | K021337 | 000 |
| B4905003015 | K021337 | 000 |
| B4905002036 | K021337 | 000 |
| B4905002035 | K021337 | 000 |
| B4905002026 | K021337 | 000 |
| B4905002025 | K021337 | 000 |
| B49050020163 | K021337 | 000 |
| B4905004026 | K021337 | 000 |
| B4905004035 | K021337 | 000 |
| B4905004036 | K021337 | 000 |
| B4905001056 | K021337 | 000 |
| B4905001055 | K021337 | 000 |
| B4905001046 | K021337 | 000 |
| B4905001045 | K021337 | 000 |
| B4905001036 | K021337 | 000 |
| B4905001035 | K021337 | 000 |
| B4905001026 | K021337 | 000 |
| B4905001025 | K021337 | 000 |
| B4905001016 | K021337 | 000 |
| B4905001015 | K021337 | 000 |
| B4905004046 | K021337 | 000 |
| B4905004045 | K021337 | 000 |
| B4905002016 | K021337 | 000 |
| B4905001055A0 | K021337 | 000 |
| B4905004046A0 | K021337 | 000 |
| B4905003026D0 | K021337 | 000 |
| B49050030262E0 | K021337 | 000 |
| B4905003025D0 | K021337 | 000 |
| B49050030252E0 | K021337 | 000 |
| B4905003016D0 | K021337 | 000 |
| B49050030162E0 | K021337 | 000 |
| B4905003015D0 | K021337 | 000 |
| B49050030152E0 | K021337 | 000 |
| B4905002036B0 | K021337 | 000 |
| B49050020362C0 | K021337 | 000 |
| B49050020362B0 | K021337 | 000 |
| B4905002035B0 | K021337 | 000 |
| B49050040152A0 | K021337 | 000 |
| B4905004015A0 | K021337 | 000 |
| B49050040162A0 | K021337 | 000 |
| B49050040462A0 | K021337 | 000 |
| B4905004045A0 | K021337 | 000 |
| B49050040452A0 | K021337 | 000 |
| B4905004036A0 | K021337 | 000 |
| B49050040362A0 | K021337 | 000 |
| B4905004035A0 | K021337 | 000 |
| B49050040352A0 | K021337 | 000 |
| B4905004026A0 | K021337 | 000 |
| B49050040262A0 | K021337 | 000 |
| B4905004025A0 | K021337 | 000 |
| B49050040252A0 | K021337 | 000 |
| B4905004016A0 | K021337 | 000 |
| B49050020359B0 | K021337 | 000 |
| B49050020359A0 | K021337 | 000 |
| B49050020352C0 | K021337 | 000 |
| B49050020062A0 | K021337 | 000 |
| B4905002005A0 | K021337 | 000 |
| B49050020052B0 | K021337 | 000 |
| B49050020052A0 | K021337 | 000 |
| B4905001066A0 | K021337 | 000 |
| B49050010662B0 | K021337 | 000 |
| B49050010662A0 | K021337 | 000 |
| B4905001065A0 | K021337 | 000 |
| B49050010652B0 | K021337 | 000 |
| B49050010652A0 | K021337 | 000 |
| B4905001056A0 | K021337 | 000 |
| B49050010562B0 | K021337 | 000 |
| B4905002006A0 | K021337 | 000 |
| B49050020152C0 | K021337 | 000 |
| B49050020159A0 | K021337 | 000 |
| B4905002026B0 | K021337 | 000 |
| B49050020262C0 | K021337 | 000 |
| B49050020262B0 | K021337 | 000 |
| B4905002025B0 | K021337 | 000 |
| B49050020252C0 | K021337 | 000 |
| B49050020252B0 | K021337 | 000 |
| B4905002016B0 | K021337 | 000 |
| B49050020169B0 | K021337 | 000 |
| B49050020169A0 | K021337 | 000 |
| B49050020162C0 | K021337 | 000 |
| B4905002015B0 | K021337 | 000 |
| B49050020159B0 | K021337 | 000 |
| B49050010562A0 | K021337 | 000 |