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 |