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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
510(k) Number K182732
Device Name JTL-250-01
Applicant
Jointechlabs, Inc.
8 Graystone Court
North Barrington,  IL  60010
Applicant Contact Thomas Lawson
Correspondent
Jointechlabs, Inc.
8 Graystone Court
North Barrington,  IL  60010
Correspondent Contact Thomas Lawson
Regulation Number878.5040
Classification Product Code
MUU  
Date Received09/28/2018
Decision Date 11/18/2019
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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