The following data is part of a premarket notification filed by Haemonetics Corporation with the FDA for Teg 6s Hemostasis System.
| Device ID | K160502 |
| 510k Number | K160502 |
| Device Name: | TEG 6s Hemostasis System |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | Haemonetics Corporation 400 Wood Road Braintree, MA 02184 |
| Contact | Paige Sweeney |
| Correspondent | Paige Sweeney Haemonetics Corporation 400 Wood Road Braintree, MA 02184 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-23 |
| Decision Date | 2017-04-19 |
| Summary: | summary |