The following data is part of a premarket notification filed by International Medical Industries, Inc. with the FDA for Tamper Evident Cap With Male Luer Lock.
| Device ID | K182545 |
| 510k Number | K182545 |
| Device Name: | Tamper Evident Cap With Male Luer Lock |
| Classification | Set, Administration, Intravascular |
| Applicant | International Medical Industries, Inc. 2981 Gateway Drive Pompano Beach, FL 33069 |
| Contact | Kathleen Lavender |
| Correspondent | Kathleen Lavender International Medical Industries, Inc. 2981 Gateway Drive Pompano Beach, FL 33069 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-17 |
| Decision Date | 2019-01-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B2125791R2 | K182545 | 000 |
| B21257352W0 | K182545 | 000 |
| B21257352R0 | K182545 | 000 |
| B21257352B0 | K182545 | 000 |
| B21257302W2 | K182545 | 000 |
| B21257302B0 | K182545 | 000 |