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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 K130123
Device Name BASIC AND DOMINANT FLEX SUCTION PUMPS
Applicant
Medela AG
W324 S3649 County Rd. E
Dousman,  WI  53118
Applicant Contact ADRIENNE LENZ
Correspondent
Medela AG
W324 S3649 County Rd. E
Dousman,  WI  53118
Correspondent Contact ADRIENNE LENZ
Regulation Number878.4780
Classification Product Code
BTA  
Subsequent Product Code
HDB  
Date Received01/17/2013
Decision Date 10/11/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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