The following data is part of a premarket notification filed by Dominion Medical Devices, Llc with the FDA for Ez Vein Inflatable Tourniquet.
| Device ID | K112874 |
| 510k Number | K112874 |
| Device Name: | EZ VEIN INFLATABLE TOURNIQUET |
| Classification | Tourniquet, Pneumatic |
| Applicant | DOMINION MEDICAL DEVICES, LLC P.O. BOX 560 Stillwater, MN 55082 |
| Contact | Elaine Duncan |
| Correspondent | Elaine Duncan DOMINION MEDICAL DEVICES, LLC P.O. BOX 560 Stillwater, MN 55082 |
| Product Code | KCY |
| CFR Regulation Number | 878.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-30 |
| Decision Date | 2011-10-17 |
| Summary: | summary |