The following data is part of a premarket notification filed by Kulzer, Inc. with the FDA for Formasil(r)a Polyvinyl Siloxane Line.
| Device ID | K901681 |
| 510k Number | K901681 |
| Device Name: | FORMASIL(R)A POLYVINYL SILOXANE LINE |
| Classification | Material, Impression |
| Applicant | KULZER, INC. 680 N. LAKE SHORE DR. SUITE 901 Chicago, IL 60611 |
| Contact | An-shih Cheng |
| Correspondent | An-shih Cheng KULZER, INC. 680 N. LAKE SHORE DR. SUITE 901 Chicago, IL 60611 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-11 |
| Decision Date | 1990-06-15 |