The following data is part of a premarket notification filed by Haemonetics Corp. with the FDA for Haemonetics Therapeutic Plasma Exchange Set.
| Device ID | K953681 |
| 510k Number | K953681 |
| Device Name: | HAEMONETICS THERAPEUTIC PLASMA EXCHANGE SET |
| Classification | Separator, Automated, Blood Cell And Plasma, Therapeutic |
| Applicant | HAEMONETICS CORP. 400 WOOD RD. P.O. BOX 9114 Braintree, MA 02184 |
| Contact | Alicia R Lopez |
| Correspondent | Alicia R Lopez HAEMONETICS CORP. 400 WOOD RD. P.O. BOX 9114 Braintree, MA 02184 |
| Product Code | LKN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-07 |
| Decision Date | 1996-06-04 |
| Summary: | summary |