The following data is part of a premarket notification filed by Haemonetics Corp. with the FDA for Haemonetics Cell Saver Mini Saver Auto. Blood Sys..
| Device ID | K872895 |
| 510k Number | K872895 |
| Device Name: | HAEMONETICS CELL SAVER MINI SAVER AUTO. BLOOD SYS. |
| Classification | Laryngoscope, Non-rigid |
| Applicant | HAEMONETICS CORP. 400 WOOD RD. P.O. BOX 9114 Braintree, MA 02184 |
| Contact | Diana G Tower |
| Correspondent | Diana G Tower HAEMONETICS CORP. 400 WOOD RD. P.O. BOX 9114 Braintree, MA 02184 |
| Product Code | CAL |
| CFR Regulation Number | 868.5530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-23 |
| Decision Date | 1988-01-11 |