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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
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