The following data is part of a premarket notification filed by Aesthetic And Reconstructive Technologies, Inc. with the FDA for Aart Chin Implant.
Device ID | K021417 |
510k Number | K021417 |
Device Name: | AART CHIN IMPLANT |
Classification | Prosthesis, Chin, Internal |
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 | FWP |
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 |
---|---|---|
B490400303B0 | K021417 | 000 |
B490400101B0 | K021417 | 000 |
B4904001022A0 | K021417 | 000 |
B490400102B0 | K021417 | 000 |
B4904001032A0 | K021417 | 000 |
B490400103B0 | K021417 | 000 |
B4904001042A0 | K021417 | 000 |
B490400104B0 | K021417 | 000 |
B4904002012A0 | K021417 | 000 |
B490400201B0 | K021417 | 000 |
B4904002022A0 | K021417 | 000 |
B490400202B0 | K021417 | 000 |
B4904003012A0 | K021417 | 000 |
B490400301B0 | K021417 | 000 |
B4904003022A0 | K021417 | 000 |
B490400302B0 | K021417 | 000 |
B4904003032A0 | K021417 | 000 |
B4904001012A0 | K021417 | 000 |