The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Flextime Magnum 360.
| Device ID | K003930 |
| 510k Number | K003930 |
| Device Name: | FLEXTIME MAGNUM 360 |
| Classification | Material, Impression |
| Applicant | HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD. South Bend, IN 46614 -2517 |
| Contact | Cheryl Zimmerman |
| Correspondent | Cheryl Zimmerman HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD. South Bend, IN 46614 -2517 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-20 |
| Decision Date | 2001-02-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J014660410650 | K003930 | 000 |