The following data is part of a premarket notification filed by Amedic Usa with the FDA for Extended Covers, Sterile.
| Device ID | K892069 |
| 510k Number | K892069 |
| Device Name: | EXTENDED COVERS, STERILE |
| Classification | Cover, Biopsy Forceps |
| Applicant | AMEDIC USA OXENSTIERNSGATAN 31 115 27 STOCKHOLM Sweden, SE |
| Contact | Anders Weilandt |
| Correspondent | Anders Weilandt AMEDIC USA OXENSTIERNSGATAN 31 115 27 STOCKHOLM Sweden, SE |
| Product Code | FFF |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-31 |
| Decision Date | 1989-08-08 |