The following data is part of a premarket notification filed by Inviro Medical Devices, Inc. with the FDA for Invirosnap 50 And 100 Unit Insulin Safety Syringes.
| Device ID | K092413 |
| 510k Number | K092413 |
| Device Name: | INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES |
| Classification | Syringe, Antistick |
| 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 | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-07 |
| Decision Date | 2009-09-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10818392015895 | K092413 | 000 |
| 10818392015888 | K092413 | 000 |
| 10818392015710 | K092413 | 000 |
| 20818392014901 | K092413 | 000 |
| 20818392014802 | K092413 | 000 |
| 10818392013921 | K092413 | 000 |
| 20818392011078 | K092413 | 000 |