The following data is part of a premarket notification filed by Emcyte Corporation with the FDA for Progenikine Concentrating System 25 Ml System.
| Device ID | K191564 |
| 510k Number | K191564 |
| Device Name: | Progenikine Concentrating System 25 ML System |
| Classification | System, Suction, Lipoplasty |
| Applicant | Emcyte Corporation 4331 Veronica S. Shoemaker Blvd, Suite 4 Fort Meyers, FL 33916 |
| Contact | Patrick Pennie |
| Correspondent | Patrick Pennie Emcyte Corporation 4331 Veronica S. Shoemaker Blvd, Suite 4 Fort Meyers, FL 33916 |
| Product Code | MUU |
| CFR Regulation Number | 878.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-13 |
| Decision Date | 2019-11-07 |