The following data is part of a premarket notification filed by Three Circles Consulting Limited with the FDA for Nutricare Clear-isosaf Nasogastric Feeding Tube.
Device ID | K202357 |
510k Number | K202357 |
Device Name: | Nutricare Clear-ISOSAF Nasogastric Feeding Tube |
Classification | Gastrointestinal Tubes With Enteral Specific Connectors |
Applicant | Three Circles Consulting Limited MED IC4, Keele University Science & Innovation Park Keele, GB St5 5nl |
Contact | Matthew Theobald |
Correspondent | Matthew Theobald GBUK Group Limited Blackwood Hall Business Park, North Duffield Selby, GB Y08 5dd |
Product Code | PIF |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-08-19 |
Decision Date | 2020-10-01 |