The following data is part of a premarket notification filed by Haemonetics Corp. with the FDA for Cell Saver Elite.
| Device ID | K120586 |
| 510k Number | K120586 |
| Device Name: | CELL SAVER ELITE |
| Classification | Apparatus, Autotransfusion |
| Applicant | HAEMONETICS CORP. 4925 Robert J Mathews Pkwy Ste 100 El Dorado Hills, CA 95762 |
| Contact | Greg Calder |
| Correspondent | Greg Calder HAEMONETICS CORP. 4925 Robert J Mathews Pkwy Ste 100 El Dorado Hills, CA 95762 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-27 |
| Decision Date | 2012-05-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30812747016616 | K120586 | 000 |