The following data is part of a premarket notification filed by Inviro Medical Devices, Inc. with the FDA for Invirostripe 3ml, 5ml, 10ml Luer Lock Syringes.
| Device ID | K081436 |
| 510k Number | K081436 |
| Device Name: | INVIROSTRIPE 3ML, 5ML, 10ML LUER LOCK SYRINGES |
| Classification | Syringe, Piston |
| Applicant | INVIRO MEDICAL DEVICES, INC. 1755 NORTH BROWN ROAD SUITE 150 Lawrenceville, GA 30043 |
| Contact | Robert N Clark |
| Correspondent | Robert N Clark INVIRO MEDICAL DEVICES, INC. 1755 NORTH BROWN ROAD SUITE 150 Lawrenceville, GA 30043 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-21 |
| Decision Date | 2008-10-22 |
| Summary: | summary |