The following data is part of a premarket notification filed by Scandinavian Medical Jw Ab with the FDA for Tourni-comp.
| Device ID | K954103 |
| 510k Number | K954103 |
| Device Name: | TOURNI-COMP |
| Classification | Tourniquet, Pneumatic |
| Applicant | SCANDINAVIAN MEDICAL JW AB 555 THIRTEENTH STREET, NW WASHINGTON, DC 20004 |
| Contact | JONATHAN S KAHAN |
| Correspondent | JONATHAN S KAHAN SCANDINAVIAN MEDICAL JW AB 555 THIRTEENTH STREET, NW WASHINGTON, DC 20004 |
| Product Code | KCY |
| CFR Regulation Number | 878.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-31 |
| Decision Date | 1995-11-01 |