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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, muscle, powered
510(k) Number K210002
Device Name STELLA BIO
Applicant
EGZOTech Sp. z o. o.
Romualda Traugutta 6H
Gliwice,  PL 44-100
Applicant Contact Michal Mikulski
Correspondent
mdi Consultants, Inc.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Correspondent Contact Vaibhav Arvind Rajal
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Codes
GZI   GZJ   HCC   KPI   NGX  
NUH   NYN  
Date Received01/04/2021
Decision Date 10/01/2021
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
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