The following data is part of a premarket notification filed by Inviro Medical Devices, Inc. with the FDA for Invirosnap Safety Syringe, Models 120006, 120007, 120008, 100080, 130022, 130023 And 130024.
| Device ID | K070203 |
| 510k Number | K070203 |
| Device Name: | INVIROSNAP SAFETY SYRINGE, MODELS 120006, 120007, 120008, 100080, 130022, 130023 AND 130024 |
| Classification | Syringe, Antistick |
| Applicant | INVIRO MEDICAL DEVICES, INC. 3235 SATELLITE BLVD. BLDG. 400, STE. 300 Duluth, GA 30096 |
| Contact | Jim Barley |
| Correspondent | Jim Barley INVIRO MEDICAL DEVICES, INC. 3235 SATELLITE BLVD. BLDG. 400, STE. 300 Duluth, GA 30096 |
| Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-22 |
| Decision Date | 2007-04-23 |
| Summary: | summary |