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 |