DURA MATER
FDA 510(k) clearance K910447 · decided 1992-06-09
Clearance details
- K-number
- K910447
- Device name
- DURA MATER
- Applicant
- Lifelink Foundation Tissue Bank
- Decision
- Substantially Equivalent
- Date received
- 1991-01-18
- Decision date
- 1992-06-09
- Days to decision
- 508 days
- Clearance type
- Traditional
- Product code
- LEM
- Device class
- 2
- Regulation number
- 882.5975
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Tampa, FL, 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 |
|---|---|---|
| TUTOPLAST DURA (K910555) | Pfrimmer-Viggo GmbH & Co. | 1992-04-20 |
Recalls involving this device
No recalls on record reference this clearance.