The following data is part of a premarket notification filed by Haemonetics Corp. with the FDA for Cell Saver 5 System.
| Device ID | K932890 |
| 510k Number | K932890 |
| Device Name: | CELL SAVER 5 SYSTEM |
| Classification | Apparatus, Autotransfusion |
| Applicant | HAEMONETICS CORP. 400 WOOD RD. P.O. BOX 9114 Braintree, MA 02184 |
| Contact | Matthew Nowland |
| Correspondent | Matthew Nowland 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-14 |
| Decision Date | 1994-01-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30812747016814 | K932890 | 000 |
| 10812747016025 | K932890 | 000 |
| 30812747016036 | K932890 | 000 |
| 30812747016043 | K932890 | 000 |
| 10812747016063 | K932890 | 000 |
| 30812747016074 | K932890 | 000 |
| 30812747016098 | K932890 | 000 |
| 30812747016104 | K932890 | 000 |
| 30812747016111 | K932890 | 000 |
| 30812747016128 | K932890 | 000 |
| 30812747016135 | K932890 | 000 |
| 30812747016142 | K932890 | 000 |
| 30812747016265 | K932890 | 000 |
| 30812747016272 | K932890 | 000 |
| 30812747016340 | K932890 | 000 |
| 30812747016487 | K932890 | 000 |
| 30812747015169 | K932890 | 000 |