The following data is part of a premarket notification filed by Haemonetics Corp. with the FDA for Haemonetics Ln 193 Disposable Set, For Use With The Haemonetics Cellsever Haemolite 2 Family Of Autologous Blood Recover.
| Device ID | K993581 |
| 510k Number | K993581 |
| Device Name: | HAEMONETICS LN 193 DISPOSABLE SET, FOR USE WITH THE HAEMONETICS CELLSEVER HAEMOLITE 2 FAMILY OF AUTOLOGOUS BLOOD RECOVER |
| Classification | Apparatus, Autotransfusion |
| 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 | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-22 |
| Decision Date | 1999-11-18 |
| Summary: | summary |