The following data is part of a premarket notification filed by Meinntech Co., Ltd. with the FDA for Ez Regular.
| Device ID | K080303 |
| 510k Number | K080303 |
| Device Name: | EZ REGULAR |
| Classification | Set, Administration, Intravascular |
| Applicant | MEINNTECH CO., LTD. PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm MEINNTECH CO., LTD. PO BOX 7007 Deerfield, IL 60015 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-05 |
| Decision Date | 2008-08-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38809289430217 | K080303 | 000 |
| 38809289430163 | K080303 | 000 |
| 38809289430101 | K080303 | 000 |