The following data is part of a premarket notification filed by Parkell with the FDA for Mousse, Polyvinyl Siloxane Impression Material.
| Device ID | K905032 |
| 510k Number | K905032 |
| Device Name: | MOUSSE, POLYVINYL SILOXANE IMPRESSION MATERIAL |
| Classification | Material, Impression |
| Applicant | PARKELL 155 SCHMITT BLVD. P.O. BOX 376 Farmingdale, NY 11735 |
| Contact | Nelson J Gendusa |
| Correspondent | Nelson J Gendusa PARKELL 155 SCHMITT BLVD. P.O. BOX 376 Farmingdale, NY 11735 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-07 |
| Decision Date | 1991-03-15 |