The following data is part of a premarket notification filed by Tag Medical Products with the FDA for Siis#1 Tissue Suspension System.
| Device ID | K020705 |
| 510k Number | K020705 |
| Device Name: | SIIS#1 TISSUE SUSPENSION SYSTEM |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| Applicant | TAG MEDICAL PRODUCTS Kibbutz Gaaton, IL 25130 |
| Contact | Dan Moor |
| Correspondent | Dan Moor TAG MEDICAL PRODUCTS Kibbutz Gaaton, IL 25130 |
| Product Code | OTN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-04 |
| Decision Date | 2002-04-26 |
| Summary: | summary |