510(k) K051190
- Device
- XENFORM SOFT TISSUE REPAIR MATRIX
- Applicant
- TEI BIOSCIENCES INC.
- 510(k) number
- K051190
- Product code
- PAJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-06-10
- Date received
- 2005-05-10
- Regulation
- 878.3300
- Classification name
- Mesh, Surgical, Non-synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
- Medical specialty
- General & Plastic Surgery
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KENNETH JAMES
- Address
- 7 Elkins St. Boston MA US 02127 02127
FDA Registration Numbers#
- 2183620
- 1000393132
- 3002924436
- 3004464325
- 3008868758
- 2530154
- 3009882464
- 3004681519
- 1416980
- 2030598
- 1048735
- 1047843
- 1835959
- 3002719998
- 3006017180
Source Documents#
Other 510(k) Records For Product Code PAJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K002233 | BVI SLING | Bio-Vascular, Inc. | 2000-10-13 |
Legacy Summary#
summary
FDA Review#
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