The following data is part of a premarket notification filed by Sainath Intellectual Properties, Llc with the FDA for Iyunni 3id Suprapubic Cystostomy Tube Kit.
| Device ID | K102572 |
| 510k Number | K102572 |
| Device Name: | IYUNNI 3ID SUPRAPUBIC CYSTOSTOMY TUBE KIT |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | SAINATH INTELLECTUAL PROPERTIES, LLC 501 E KENNEDY BLVD. SUITE 1700 Tampa, FL 33602 |
| Contact | Christopher Paradies, Ph.d. |
| Correspondent | Christopher Paradies, Ph.d. SAINATH INTELLECTUAL PROPERTIES, LLC 501 E KENNEDY BLVD. SUITE 1700 Tampa, FL 33602 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-08 |
| Decision Date | 2010-12-27 |
| Summary: | summary |