The following data is part of a premarket notification filed by Aesthetic And Reconstructive Technologies, Inc. with the FDA for Aart Silicone Tubing.
Device ID | K022306 |
510k Number | K022306 |
Device Name: | AART SILICONE TUBING |
Classification | Accessories, Catheter |
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 | KGZ |
CFR Regulation Number | 878.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-07-16 |
Decision Date | 2002-10-10 |