510(k) K050355
- Device
- PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MODELS 5928-150, 5645-150
- Applicant
- TISSUE SCIENCE LABORATORIES, PLC
- 510(k) number
- K050355
- Product code
- PAI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-03-09
- Date received
- 2005-02-14
- 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
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- VICTORIA TAYLOR
- Address
- 1141 Clark St., Suite D Covington GA US 30014 30014
FDA Registration Numbers#
- 1048735
- 1018233
Source Documents#
Other 510(k) Records For Product Code PAI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K130006 | BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS | Cook Biotech Incorporated | 2013-04-05 |
Legacy Summary#
summary
FDA Review#
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