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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Microfilter, Blood Transfusion
510(k) Number K061103
Device Name HAEMONETICS 40U RBC FILTER BAG
Applicant
Haemonetics Corp.
400 Wood Rd.
P.O. Box 9114
Braintree,  MA  02184
Applicant Contact GABRIEL J MURACA
Correspondent
Tuv Rheinland of North America, Inc.
12 Commerce Rd.
Newton,  CT  06470
Correspondent Contact TAMAS BORSAI
Regulation Number880.5440
Classification Product Code
CAK  
Date Received04/20/2006
Decision Date 05/17/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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