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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name pump, portable, aspiration (manual or powered)
510(k) Number K052626
Device Name SMARTSUCTION HARMONY DEVICE
Applicant
HAEMONETICS CORP.
400 WOOD ROAD
BRAINTREE,  MA  02184 -9114
Applicant Contact GABRIEL J MURACA
Correspondent
TUV RHEINLAND OF NORTH AMERICA, INC.
12 COMMERCE RD.
NEWTON,  CT  06470
Correspondent Contact TAMAS BORSAI
Regulation Number878.4780
Classification Product Code
BTA  
Date Received09/23/2005
Decision Date 10/05/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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