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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 K213577
Device Name VenAir, Sequential Compression System
Applicant
Apex Medical Corp.
# 9, Min Sheng St., Tu-Cheng,
New Taipei City,  TW 23679
Applicant Contact Chieh Yang
Correspondent
Apex Medical Corp.
# 9, Min Sheng St., Tu-Cheng,
New Taipei City,  TW 23679
Correspondent Contact Chieh Yang
Regulation Number870.5800
Classification Product Code
JOW  
Date Received11/10/2021
Decision Date 06/28/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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