The following data is part of a premarket notification filed by Orthofab, Inc. with the FDA for Digikit Nonpneumatic Tourniquet.
| Device ID | K860095 |
| 510k Number | K860095 |
| Device Name: | DIGIKIT NONPNEUMATIC TOURNIQUET |
| Classification | Tourniquet, Pneumatic |
| Applicant | ORTHOFAB, INC. 7464 IRVIN AVE. SOUTH Cottage Grove, MN 55016 |
| Contact | Thomas H Barrows |
| Correspondent | Thomas H Barrows ORTHOFAB, INC. 7464 IRVIN AVE. SOUTH Cottage Grove, MN 55016 |
| Product Code | KCY |
| CFR Regulation Number | 878.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-10 |
| Decision Date | 1986-01-24 |