The following data is part of a premarket notification filed by Inviro Medical Devices, Inc. with the FDA for Inviroblunt Cannula With And Without Ez Wings, Models 120522 And 120022.
| Device ID | K083851 |
| 510k Number | K083851 |
| Device Name: | INVIROBLUNT CANNULA WITH AND WITHOUT EZ WINGS, MODELS 120522 AND 120022 |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | INVIRO MEDICAL DEVICES, INC. 1755 NORTH BROWN ROAD SUITE 150 Lawrenceville, GA 30043 |
| Contact | Jim Barley |
| Correspondent | Jim Barley INVIRO MEDICAL DEVICES, INC. 1755 NORTH BROWN ROAD SUITE 150 Lawrenceville, GA 30043 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-24 |
| Decision Date | 2009-05-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20818392015298 | K083851 | 000 |
| 10818392013907 | K083851 | 000 |
| 10304040017040 | K083851 | 000 |
| 10304040016814 | K083851 | 000 |