XENFORM SOFT TISSUE REPAIR MATRIX
FDA 510(k) clearance K051190 · decided 2005-06-10
Clearance details
- K-number
- K051190
- Device name
- XENFORM SOFT TISSUE REPAIR MATRIX
- Applicant
- Tei Biosciences, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-05-10
- Decision date
- 2005-06-10
- Days to decision
- 31 days
- Clearance type
- Special
- Product code
- PAJ
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Boston, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BVI SLING (K002233) | Bio-Vascular, Inc. | 2000-10-13 |
Recalls involving this device
No recalls on record reference this clearance.