The following data is part of a premarket notification filed by Pfrimmer-viggo Gmbh & Co. with the FDA for Tutoplast Dura.
| Device ID | K910555 |
| 510k Number | K910555 |
| Device Name: | TUTOPLAST DURA |
| Classification | Human Lyophilized Dura Mater |
| Applicant | PFRIMMER-VIGGO GMBH & CO. C/O KLEINFELD, KAPLAN & BECKER 1140 NINETEENTH STREET, N. W. Washington, DC 20036 |
| Contact | Alan H Kaplan |
| Correspondent | Alan H Kaplan PFRIMMER-VIGGO GMBH & CO. C/O KLEINFELD, KAPLAN & BECKER 1140 NINETEENTH STREET, N. W. Washington, DC 20036 |
| Product Code | LEM |
| CFR Regulation Number | 882.5975 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-07 |
| Decision Date | 1992-04-20 |