The following data is part of a premarket notification filed by Cavex Holland B.v. with the FDA for Krom-alginate And Alginate Plus.
| Device ID | K000686 |
| 510k Number | K000686 |
| Device Name: | KROM-ALGINATE AND ALGINATE PLUS |
| Classification | Material, Impression |
| Applicant | CAVEX HOLLAND B.V. PO BOX 852 Rw Haarlem (holland), NL 2003 |
| Contact | Richard Woortman |
| Correspondent | Richard Woortman CAVEX HOLLAND B.V. PO BOX 852 Rw Haarlem (holland), NL 2003 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-29 |
| Decision Date | 2000-05-25 |