The following data is part of a premarket notification filed by Cook Biotech, Inc. with the FDA for Surgisis Sling.
| Device ID | K992159 |
| 510k Number | K992159 |
| Device Name: | SURGISIS SLING |
| Classification | Mesh, Surgical, Non-synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| Applicant | COOK BIOTECH, INC. 3055 KENT AVE. West Lafayette, IN 47906 -1076 |
| Contact | Neal E Fearnot |
| Correspondent | Neal E Fearnot COOK BIOTECH, INC. 3055 KENT AVE. West Lafayette, IN 47906 -1076 |
| Product Code | PAG |
| Subsequent Product Code | FTM |
| Subsequent Product Code | PAJ |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-25 |
| Decision Date | 1999-09-23 |
| Summary: | summary |