The following data is part of a premarket notification filed by Bisico Gmbh & Co Kg with the FDA for Bisico Impression Silicones & Alginates.
| Device ID | K072577 |
| 510k Number | K072577 |
| Device Name: | BISICO IMPRESSION SILICONES & ALGINATES |
| Classification | Material, Impression |
| Applicant | BISICO GMBH & CO KG AMSTEL 320-I Amsterdam, NL 33611 |
| Contact | Dagmar Maeser |
| Correspondent | Dagmar Maeser BISICO GMBH & CO KG AMSTEL 320-I Amsterdam, NL 33611 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-13 |
| Decision Date | 2007-12-05 |