The following data is part of a premarket notification filed by Carticept Medical Inc with the FDA for Navigator Aesthetic Delivery System.
| Device ID | K151255 |
| 510k Number | K151255 |
| Device Name: | Navigator Aesthetic Delivery System |
| Classification | Pump, Infusion |
| Applicant | CARTICEPT MEDICAL INC 6120 WINDWARD PRKWY SUITE 220 Alpharetta, GA 30005 |
| Contact | Carribeth Ramey |
| Correspondent | Rachel Kennedy Regulatory And Clinical Research Institute 5353 Wayzata Blvd, Suite 505 Minneapolis, MN 55416 -1334 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-12 |
| Decision Date | 2015-12-30 |
| Summary: | summary |