The following data is part of a premarket notification filed by Ingeneron, Inc. with the FDA for Smartgraft 30 System.
| Device ID | K141591 |
| 510k Number | K141591 |
| Device Name: | SMARTGRAFT 30 SYSTEM |
| Classification | System, Suction, Lipoplasty |
| Applicant | INGENERON, INC. 8205 EL RIO Houston, TX 77054 |
| Contact | Anita Kadala |
| Correspondent | Anita Kadala INGENERON, INC. 8205 EL RIO Houston, TX 77054 |
| Product Code | MUU |
| CFR Regulation Number | 878.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-13 |
| Decision Date | 2014-09-24 |
| Summary: | summary |