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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 K153663
Device Name Vario 8/18/ci
Applicant
Medela AG
Lattichstrasse 4b
Baar,  CH 6341
Applicant Contact MARKUS BUTLER
Correspondent
Pathway Regulatory Consulting, LLC
W324 S3649 County Rd. E
Dousman,  WI  53118
Correspondent Contact ADRIENNE LENZ
Regulation Number878.4780
Classification Product Code
BTA  
Date Received12/21/2015
Decision Date 05/18/2016
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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