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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 K232270
Device Name DVT Motion Pneumatic Compression Device
Applicant
Koge Micro Tech Co., Ltd.
5f., # 6, Jiankang Rd. 1, Zhonghe Dist.
New Taipei,  TW 23586
Applicant Contact Doris Chiu
Correspondent
Koge Micro Tech Co., Ltd.
5f., # 6, Jiankang Rd. 1, Zhonghe Dist.
New Taipei,  TW 23586
Correspondent Contact Doris Chiu
Regulation Number870.5800
Classification Product Code
JOW  
Date Received07/31/2023
Decision Date 03/06/2024
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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