510(k) K910447
- Device
- DURA MATER
- Applicant
- LIFELINK FOUNDATION TISSUE BANK
- 510(k) number
- K910447
- Product code
- LEM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-06-09
- Date received
- 1991-01-18
- Regulation
- 882.5975
- Classification name
- Human Lyophilized Dura Mater
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVE SHIRES
- Address
- 8510 Sunstate St. Tampa FL US 33634 33634
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LEM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K910555 | TUTOPLAST DURA | Pfrimmer-Viggo GmbH & Co. | 1992-04-20 |
Legacy Summary#
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FDA Review#
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