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 | K190225 |
| 510k Number | K190225 |
| Device Name: | TAP Blood Collection Device |
| Classification | Capillary Blood Collection Device For Alternative Site Collection |
| Applicant | Seventh Sense Biosystems, Inc. 200 Boston Avenue, Suite 3700 Medford, MA 02155 |
| Contact | Tim Richards |
| Correspondent | Tim Richards Seventh Sense Biosystems, Inc. 200 Boston Avenue, Suite 3700 Medford, MA 02155 |
| Product Code | PRJ |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-05 |
| Decision Date | 2019-11-05 |