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 | K122215 |
510k Number | K122215 |
Device Name: | NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) |
Classification | Pump, Infusion |
Applicant | CARTICEPT MEDICAL, INC. 6120 Windward Pkwy Ste 220 Alpharetta, GA 30005 |
Contact | Tanya Eberle |
Correspondent | Tanya Eberle CARTICEPT MEDICAL, INC. 6120 Windward Pkwy Ste 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 | 2012-07-25 |
Decision Date | 2012-10-26 |
Summary: | summary |