The following data is part of a premarket notification filed by Haemonetics Corp. with the FDA for Autoflo Intra-op Shed Blood Autortransfustion Sys.
| Device ID | K944232 |
| 510k Number | K944232 |
| Device Name: | AUTOFLO INTRA-OP SHED BLOOD AUTORTRANSFUSTION SYS |
| 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 | 1994-09-01 |
| Decision Date | 1995-07-20 |