The following data is part of a premarket notification filed by Novus Scientific Pte Ltd with the FDA for Tigr Surgical Mesh , Model Wk-6.
| Device ID | K092224 |
| 510k Number | K092224 |
| Device Name: | TIGR SURGICAL MESH , MODEL WK-6 |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | NOVUS SCIENTIFIC PTE LTD NORDIC EUROPEAN CENTRE, 3 INTERNATIONAL BUSINESS PARK #01-20, Singapore, SG 609927 |
| Contact | Kelvin Koh |
| Correspondent | Kelvin Koh NOVUS SCIENTIFIC PTE LTD NORDIC EUROPEAN CENTRE, 3 INTERNATIONAL BUSINESS PARK #01-20, Singapore, SG 609927 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-23 |
| Decision Date | 2010-01-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332999000093 | K092224 | 000 |
| 07332999000024 | K092224 | 000 |
| 07332999000017 | K092224 | 000 |