The following data is part of a premarket notification filed by Haemonetics Corp. with the FDA for Haemonetics Cell Saver 5 Autologous Blood Recovery System.
| Device ID | K014083 |
| 510k Number | K014083 |
| Device Name: | HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM |
| Classification | Apparatus, Autotransfusion |
| Applicant | HAEMONETICS CORP. 400 WOOD RD. P.O. BOX 9114 Braintree, MA 02184 |
| Contact | John Sokolowski |
| Correspondent | John Sokolowski 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 | 2001-12-11 |
| Decision Date | 2002-01-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30812747016289 | K014083 | 000 |
| 10812747015172 | K014083 | 000 |