The following data is part of a premarket notification filed by Carticept Medical Inc with the FDA for Navigator Delivery System (or Navigator Ds) Model: Nav-010.
Device ID | K101194 |
510k Number | K101194 |
Device Name: | NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR DS) MODEL: NAV-010 |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-04-28 |
Decision Date | 2011-07-11 |
Summary: | summary |