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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 K202462
Device Name SIGMA Sterilization Pouch and Roll
Applicant
Sigma Medical Supplies Corporation
#34, Ding-Ping Rd., Rui Fang Industrial Park,
Rui Fang Dist.
New Taipei City,  TW 224
Applicant Contact Ethan Lin
Correspondent
Sen MU Technology Co., Ltd.
I5f-2, #I, Lane 26, Mincyuan 1st Rd., Lingya District,
Kaohsiung City,  TW 802
Correspondent Contact Uta Shih
Regulation Number880.6850
Classification Product Code
FRG  
Subsequent Product Code
JOJ  
Date Received08/27/2020
Decision Date 04/23/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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