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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 K021368
Device Name MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057
Applicant
Medela AG
Laettichstrasse 4
Ch-6340 Baar,  CH
Applicant Contact RERNER FREI
Correspondent
Tuv America, Inc.
1775 Old Hwy. 8
New Brighton,  MN  55112
Correspondent Contact MARK JOB
Regulation Number878.4780
Classification Product Code
BTA  
Date Received04/30/2002
Decision Date 05/15/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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