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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 K180672
Device Name Sterilization Pouch/Roll Made with Tyvek
Applicant
Sigma Medical Supplies Corporation
NO.34, Ding-Ping Road, Rui Fang Industrial Park,
Rui Fang Dist.
New Taipei City,  TW 224
Applicant Contact Mason Huang
Correspondent
Sen Mu Technology Co., LTD.
15F.-2, No.1, 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 Received03/14/2018
Decision Date 06/06/2018
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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