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510(k) K052626

SMARTSUCTION HARMONY DEVICE by Haemonetics Corp. — Product Code BTA

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

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