The following data is part of a premarket notification filed by Shina Corp. with the FDA for Vacu-med Blood Collection Needles.
| Device ID | K071947 |
| 510k Number | K071947 |
| Device Name: | VACU-MED BLOOD COLLECTION NEEDLES |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | SHINA CORP. 5353 WAYZATA BOULEVARD SUITE 305 Minneapolis, MN 55416 -1334 |
| Contact | Carole Stamp |
| Correspondent | Carole Stamp SHINA CORP. 5353 WAYZATA BOULEVARD SUITE 305 Minneapolis, MN 55416 -1334 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-13 |
| Decision Date | 2007-10-12 |
| Summary: | summary |