The following data is part of a premarket notification filed by Amedic Usa with the FDA for Equip Covers, Sterile.
| Device ID | K897120 |
| 510k Number | K897120 |
| Device Name: | EQUIP COVERS, STERILE |
| Classification | Drape, Surgical |
| Applicant | AMEDIC USA OXENSTIERNSGATAN 31 115 27 STOCKHOLM Sweden, SE |
| Contact | Theo Russo-larsson |
| Correspondent | Theo Russo-larsson AMEDIC USA OXENSTIERNSGATAN 31 115 27 STOCKHOLM Sweden, SE |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-26 |
| Decision Date | 1990-01-04 |