The following data is part of a premarket notification filed by Amedic Usa with the FDA for General (biopsy) Needle Guide Kit, Sterile.
| Device ID | K892071 |
| 510k Number | K892071 |
| Device Name: | GENERAL (BIOPSY) NEEDLE GUIDE KIT, STERILE |
| Classification | Instrument, Biopsy |
| 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 | KNW |
| 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 |