The following data is part of a premarket notification filed by Seventh Sense Biosystems, Inc. with the FDA for Tap Blood Collection Device.
| Device ID | K161521 |
| 510k Number | K161521 |
| Device Name: | TAP Blood Collection Device |
| Classification | Capillary Blood Collection Device For Alternative Site Collection |
| Applicant | Seventh Sense Biosystems, Inc. 200 BOSTON AVE SUITE 3700 Medford, MA 02155 |
| Contact | Tim Richards |
| Correspondent | Sharon Timberlake Sharon Timberlake Consulting, LLC 27 Dunelm Road Bedford, MA 01730 |
| Product Code | PRJ |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-02 |
| Decision Date | 2017-02-16 |
| Summary: | summary |