The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Flexitime Flow.
| Device ID | K091494 |
| 510k Number | K091494 |
| Device Name: | FLEXITIME FLOW |
| Classification | Material, Impression |
| Applicant | HERAEUS KULZER, INC. 300 HERAEUS WAY South Bend, IN 46614 |
| Contact | Cheryl Zimmerman |
| Correspondent | Cheryl Zimmerman HERAEUS KULZER, INC. 300 HERAEUS WAY South Bend, IN 46614 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-20 |
| Decision Date | 2009-07-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J014660410620 | K091494 | 000 |
| J014660773770 | K091494 | 000 |
| J014660773780 | K091494 | 000 |
| J014400050400 | K091494 | 000 |
| J014400050410 | K091494 | 000 |
| J014600410610 | K091494 | 000 |
| J014600410611 | K091494 | 000 |
| J014600410620 | K091494 | 000 |
| J014600410621 | K091494 | 000 |
| J014660410610 | K091494 | 000 |
| J014660410710 | K091494 | 000 |