TUTOPLAST DURA
FDA 510(k) clearance K910555 · decided 1992-04-20
Clearance details
- K-number
- K910555
- Device name
- TUTOPLAST DURA
- Applicant
- Pfrimmer-Viggo GmbH & Co.
- Decision
- Substantially Equivalent
- Date received
- 1991-02-07
- Decision date
- 1992-04-20
- Days to decision
- 438 days
- Clearance type
- Traditional
- Product code
- LEM
- Device class
- 2
- Regulation number
- 882.5975
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Washington, DC, 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 |
|---|---|---|
| DURA MATER (K910447) | Lifelink Foundation Tissue Bank | 1992-06-09 |
Recalls involving this device
No recalls on record reference this clearance.