The following data is part of a premarket notification filed by Haemonetics Corp. with the FDA for Fluid Management System.
| Device ID | K852645 |
| 510k Number | K852645 |
| Device Name: | FLUID MANAGEMENT SYSTEM |
| Classification | Pump, Infusion |
| Applicant | HAEMONETICS CORP. 400 WOOD RD. P.O. BOX 9114 Braintree, MA 02184 |
| Contact | Paul H Patrone |
| Correspondent | Paul H Patrone HAEMONETICS CORP. 400 WOOD RD. P.O. BOX 9114 Braintree, MA 02184 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-21 |
| Decision Date | 1985-12-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20812747016220 | K852645 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() FLUID MANAGEMENT SYSTEM 74202113 not registered Dead/Abandoned |
SANNING, FRANK B. 1991-09-09 |