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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Suction, Lipoplasty For Removal
510(k) Number K170329
Device Name Basic, Dominant Flex
Applicant
Modela 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 Number878.5040
Classification Product Code
QPB  
Date Received02/02/2017
Decision Date 03/24/2017
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
Recalls CDRH Recalls
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