The following data is part of a premarket notification filed by Sainath Intellectual Properties, Llc with the FDA for Iyunni 3id Tri-funnel Feeding Tube Kit.
Device ID | K100173 |
510k Number | K100173 |
Device Name: | IYUNNI 3ID TRI-FUNNEL FEEDING TUBE KIT |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | SAINATH INTELLECTUAL PROPERTIES, LLC 9438 PEBBLE BEACH CT. WEST Largo, FL 33777 |
Contact | Christopher Paradies |
Correspondent | Christopher Paradies SAINATH INTELLECTUAL PROPERTIES, LLC 9438 PEBBLE BEACH CT. WEST Largo, FL 33777 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent - Kit (SESK) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-01-21 |
Decision Date | 2010-04-16 |
Summary: | summary |