The following data is part of a premarket notification filed by Zhermack S.p.a. with the FDA for Occlufast Cad.
| Device ID | K080130 |
| 510k Number | K080130 |
| Device Name: | OCCLUFAST CAD |
| Classification | Material, Impression |
| Applicant | ZHERMACK S.P.A. 19379 BLUE LAKE LOOP Bend, OR 97702 |
| Contact | Gerald W Shipps |
| Correspondent | Gerald W Shipps ZHERMACK S.P.A. 19379 BLUE LAKE LOOP Bend, OR 97702 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-18 |
| Decision Date | 2008-03-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 58033712562211 | K080130 | 000 |
| 58033712562150 | K080130 | 000 |