The following data is part of a premarket notification filed by Haemonetics Corp. with the FDA for Smartsuction Harmony Device.
| Device ID | K052626 |
| 510k Number | K052626 |
| Device Name: | SMARTSUCTION HARMONY DEVICE |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | HAEMONETICS CORP. 400 WOOD ROAD Braintree, MA 02184 -9114 |
| Contact | Gabriel J Muraca |
| Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-09-23 |
| Decision Date | 2005-10-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30812747016968 | K052626 | 000 |
| 30812747017354 | K052626 | 000 |
| 30812747017347 | K052626 | 000 |
| 30812747017330 | K052626 | 000 |