The following data is part of a premarket notification filed by Cavex Holland Bv with the FDA for Cavex Cream Alginate.
| Device ID | K151535 |
| 510k Number | K151535 |
| Device Name: | Cavex Cream Alginate |
| Classification | Material, Impression |
| Applicant | CAVEX HOLLAND BV FUSTWEG 5 Haarlem, NL 2031cj |
| Contact | Richard Woortman |
| Correspondent | Richard Woortman CAVEX HOLLAND BV FUSTWEG 5 Haarlem, NL 2031cj |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-08 |
| Decision Date | 2015-10-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E241AA6001 | K151535 | 000 |
| E241AA6000 | K151535 | 000 |