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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Powered Inflatable Tube
510(k) Number K201730
Device Name Powered Inflatable Tube Massager - SLIM UP DRAIN
Applicant
Foggiare Technologies, LLC
1920 W. Bay Dr., Suite 4
Largo,  FL  33770
Applicant Contact Thierry Germanovitch
Correspondent
Mansour Consulting, LLC
845 Aronson Lake Ct.
Roswell,  GA  30075
Correspondent Contact Jay Mansour
Regulation Number890.5650
Classification Product Code
IRP  
Date Received06/24/2020
Decision Date 08/22/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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