The following data is part of a premarket notification filed by Carticept Medical Inc with the FDA for Navigator Delivery System (navigator Ds).
| Device ID | K120830 |
| 510k Number | K120830 |
| Device Name: | NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) |
| Classification | Pump, Infusion |
| Applicant | CARTICEPT MEDICAL INC 6120 Windward Parkway Suite 220 Alpharetta, GA 30005 |
| Contact | Tanya Eberle |
| Correspondent | Tanya Eberle CARTICEPT MEDICAL INC 6120 Windward Parkway Suite 220 Alpharetta, GA 30005 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-19 |
| Decision Date | 2012-04-16 |
| Summary: | summary |