The following data is part of a premarket notification filed by International Medical Industries, Inc. with the FDA for Additive Cap.
| Device ID | K190305 |
| 510k Number | K190305 |
| Device Name: | Additive Cap |
| Classification | Container, I.v. |
| Applicant | International Medical Industries, Inc. 2981 Gateway Drive Pompano Beach, FL 33069 |
| Contact | Peter Lehel |
| Correspondent | Peter Lehel International Medical Industries, Inc. 2981 Gateway Drive Pompano Beach, FL 33069 |
| Product Code | KPE |
| CFR Regulation Number | 880.5025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-12 |
| Decision Date | 2019-04-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B21221002 | K190305 | 000 |
| B2122100B1000 | K190305 | 000 |
| B2122100B2 | K190305 | 000 |
| B21221001000 | K190305 | 000 |
| B21221031002 | K190305 | 000 |
| B21221032 | K190305 | 000 |