The following data is part of a premarket notification filed by Zhermack S.p.a. with the FDA for Freealgin.
| Device ID | K070700 |
| 510k Number | K070700 |
| Device Name: | FREEALGIN |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-13 |
| Decision Date | 2007-04-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EZHIC3001101 | K070700 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() FREEALGIN 79042365 3385814 Live/Registered |
ZHERMACK S.p.A. 2007-03-27 |