The following data is part of a premarket notification filed by Cook Biotech, Inc. with the FDA for Stratasis Sling Kit.
| Device ID | K020654 |
| 510k Number | K020654 |
| Device Name: | STRATASIS SLING KIT |
| 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 | Mark Bleyer |
| Correspondent | Mark Bleyer COOK BIOTECH, INC. 3055 KENT AVE. West Lafayette, IN 47906 -1076 |
| Product Code | PAG |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-28 |
| Decision Date | 2002-04-09 |
| Summary: | summary |