The following data is part of a premarket notification filed by International Medical Industries Inc. with the FDA for Guarded Luer Connector.
| Device ID | K173577 |
| 510k Number | K173577 |
| Device Name: | Guarded Luer Connector |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | International Medical Industries Inc. 2981 Gateway Drive Pompano Beach, FL 33069 |
| Contact | Brandon Hunt |
| Correspondent | Kathleen Lavender International Medical Industries Inc. 2981 Gateway Drive Pompano Beach, FL 33069 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-20 |
| Decision Date | 2018-06-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B212574012 | K173577 | 000 |
| B212574002 | K173577 | 000 |
| B212574032 | K173577 | 000 |
| B212574022 | K173577 | 000 |
| B21257400W1 | K173577 | 000 |