The following data is part of a premarket notification filed by Norfolk Medical with the FDA for Turbo High-flow Non-coring Needle.
| Device ID | K151341 |
| 510k Number | K151341 |
| Device Name: | Turbo High-Flow Non-coring Needle |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | NORFOLK MEDICAL 7350 N. RIDGEWAY AVENUE Skokie, IL 60076 |
| Contact | Natan Pheil |
| Correspondent | Natan Pheil NORFOLK MEDICAL 7350 N. RIDGEWAY AVENUE Skokie, IL 60076 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-19 |
| Decision Date | 2015-08-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M991TH023002 | K151341 | 000 |
| M991TH022002 | K151341 | 000 |
| M991TH021002 | K151341 | 000 |
| M991TH013002 | K151341 | 000 |
| M991TH012002 | K151341 | 000 |
| M991TH011002 | K151341 | 000 |