510(k) K130006
- Device
- BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS
- Applicant
- COOK BIOTECH INCORPORATED
- 510(k) number
- K130006
- Product code
- PAI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-04-05
- Date received
- 2013-01-02
- Regulation
- 884.5980
- Classification name
- Mesh, Surgical, Non-synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 3
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- NICK X WANG
- Address
- 1425 Innovation Pl. West Lafayette IN US 47906 47906
FDA Registration Numbers#
- 1048735
- 1018233
Source Documents#
Other 510(k) Records For Product Code PAI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K050355 | PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MODELS 5928-150, 5645-150 | Tissue Science Laboratories, Plc | 2005-03-09 |
Legacy Summary#
summary
FDA Review#
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