The following data is part of a premarket notification filed by Sainath Intellectual Properties, Llc with the FDA for Iyunni 3id Tri-funnel Gastrostomy Tube Kit.
| Device ID | K092049 |
| 510k Number | K092049 |
| Device Name: | IYUNNI 3ID TRI-FUNNEL GASTROSTOMY TUBE KIT |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | SAINATH INTELLECTUAL PROPERTIES, LLC 501 E KENNEDY BLVD. SUITE 1700 Tampa, FL 33602 |
| Contact | Christopher Paradies |
| Correspondent | Christopher Paradies SAINATH INTELLECTUAL PROPERTIES, LLC 501 E KENNEDY BLVD. SUITE 1700 Tampa, FL 33602 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-07 |
| Decision Date | 2009-10-09 |
| Summary: | summary |