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 |