The following data is part of a premarket notification filed by Haemonetics Manufacturing Inc. with the FDA for Transfer Sets.
| Device ID | BK860006 | 
| 510k Number | BK860006 | 
| Device Name: | Transfer Sets | 
| Classification | Set, Transfer (blood/plasma) | 
| Applicant | Haemonetics Manufacturing Inc. 400 Wood Road Braintree, MA 02184 | 
| Product Code | KSB | 
| CFR Regulation Number | 864.9875 [🔎] | 
| Decision | Substantially Equivalent (SE) | 
| Type | 510(k) Traditio | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1986-01-27 | 
| Decision Date | 1986-09-17 |