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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 K033179
Device Name MEDELA CLARIO HOME CARE PUMP
Applicant
MEDELA AG
LAETTICHSTRASSE 4
CH-6340 BAAR,  CH
Applicant Contact WERNER FREI
Correspondent
TUV AMERICA, INC.
1775 OLD HIGHWAY 8
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact STEFAN PREISS
Regulation Number878.4780
Classification Product Code
BTA  
Date Received10/01/2003
Decision Date 10/15/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
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