The following data is part of a premarket notification filed by Apriomed Ab with the FDA for Morrison Steerable Needle.
| Device ID | K150625 |
| 510k Number | K150625 |
| Device Name: | Morrison Steerable Needle |
| Classification | Instrument, Biopsy |
| Applicant | APRIOMED AB VIRDINGS ALLE' 28 Uppsala, SE 75450 |
| Contact | Bruno Edling |
| Correspondent | Bruno Edling APRIOMED AB VIRDINGS ALLE' 28 Uppsala, SE 75450 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-11 |
| Decision Date | 2015-06-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 27350031355509 | K150625 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MORRISON STEERABLE NEEDLE 85766654 4449240 Live/Registered |
AprioMed AB 2012-10-30 |