510(k) K910555
- Device
- TUTOPLAST DURA
- Applicant
- PFRIMMER-VIGGO GMBH & CO.
- 510(k) number
- K910555
- Product code
- LEM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-04-20
- Date received
- 1991-02-07
- 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
- ALAN H KAPLAN
- Address
- C/O Kleinfeld, Kaplan & Becker 1140 Nineteenth St., NW Washington DC US 20036 20036
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LEM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K910447 | DURA MATER | Lifelink Foundation Tissue Bank | 1992-06-09 |
Legacy Summary#
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FDA Review#
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