The following data is part of a premarket notification filed by Haemonetics Corp. with the FDA for Haemonetics 40u Rbc Filter Bag.
| Device ID | K061103 |
| 510k Number | K061103 |
| Device Name: | HAEMONETICS 40U RBC FILTER BAG |
| Classification | Microfilter, Blood Transfusion |
| Applicant | HAEMONETICS CORP. 400 WOOD RD. P.O. BOX 9114 Braintree, MA 02184 |
| Contact | Gabriel J Muraca |
| Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | CAK |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-04-20 |
| Decision Date | 2006-05-17 |
| Summary: | summary |