510(k) K052626
K052626 is an FDA 510(k) premarket notification submitted by Haemonetics Corp. for the device "SMARTSUCTION HARMONY DEVICE". The FDA issued a decision of Substantially Equivalent on October 5, 2005. The device falls under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)), a Class II device regulated under 21 CFR 878.4780. Haemonetics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 5, 2005
- Date Received
- September 23, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Pump, Portable, Aspiration (Manual Or Powered)
- Device Class
- Class II
- Regulation Number
- 878.4780
- Review Panel
- SU
- Submission Type