The following data is part of a premarket notification filed by Cook Biotech Incorporated with the FDA for Biodesign Surgisis Anterior Posterior Pelvic Floor Grafts.
| Device ID | K130006 |
| 510k Number | K130006 |
| Device Name: | BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS |
| Classification | Mesh, Surgical, Non-synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed |
| Applicant | COOK BIOTECH INCORPORATED 1425 INNOVATION PLACE West Lafayette, IN 47906 |
| Contact | Nick X Wang |
| Correspondent | Nick X Wang COOK BIOTECH INCORPORATED 1425 INNOVATION PLACE West Lafayette, IN 47906 |
| Product Code | PAI |
| CFR Regulation Number | 884.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-02 |
| Decision Date | 2013-04-05 |
| Summary: | summary |