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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K243431
Device Name Medicom Sterilization Pouch and Reel
Applicant
Medicom Asia-Pacific Holdings Ltd. Taiwan Branch.
# 11, Sec. 2, Ligong 1st Rd., Wujie Township
Yilan County,  TW 26841
Applicant Contact Kristy Lee
Correspondent
Sen MU Technology Co., Ltd.
15f.-2, #1. Ln. 26, Minquan 1st Rd., Lingya Dist
Kaohsiung City,  TW 802
Correspondent Contact Uta Shih
Regulation Number880.6850
Classification Product Code
FRG  
Subsequent Product Code
JOJ  
Date Received11/05/2024
Decision Date 02/21/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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