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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Extracellular Fluid, Lymphedema, Extremity
510(k) Number K180126
Device Name SOZO
Applicant
ImpediMed Limited
Unit 1
50 Parker Court
Pinkenba,  AU 4008
Applicant Contact Catherine Kingsford
Correspondent
ImpediMed Inc.
5900 Pasteur Court
Unit 125
Carlsbad,  CA  92009
Correspondent Contact Reuben Lawson
Regulation Number870.2770
Classification Product Code
OBH  
Date Received01/16/2018
Decision Date 04/16/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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