The following data is part of a premarket notification filed by Inviro Medical Devices, Inc. with the FDA for Invirostripe Luer Lock Syringes (1, 3, 10, 20, 30 And 60 Ml).
| Device ID | K101359 |
| 510k Number | K101359 |
| Device Name: | INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML) |
| Classification | Syringe, Piston |
| 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 | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-14 |
| Decision Date | 2010-08-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05903999600327 | K101359 | 000 |
| 05903999600310 | K101359 | 000 |