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 |