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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sleeve, Limb, Compressible
510(k) Number K232006
Device Name LEGACY® IPC
Applicant
Ig Technology, Ltd.
Wylcut House, 316 Petre St.
Sheffield,  GB S33 0AW
Applicant Contact Ivan Green
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number870.5800
Classification Product Code
JOW  
Date Received07/06/2023
Decision Date 08/04/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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