The following data is part of a premarket notification filed by Inviro Medical Devices, Inc. with the FDA for Invirolink And Inviro Tip Blunt Cannulas, Model 130001, 130501, 140001, 140002, 140003.
| Device ID | K071307 |
| 510k Number | K071307 |
| Device Name: | INVIROLINK AND INVIRO TIP BLUNT CANNULAS, MODEL 130001, 130501, 140001, 140002, 140003 |
| Classification | Needle, Hypodermic, Single Lumen |
| 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 | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-09 |
| Decision Date | 2008-02-12 |
| Summary: | summary |