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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 K133838
Device Name STERILIZATION POUCH/ROLL MADE WITH TYVEK
Applicant
Sigma Medical Supplies Corp.
15f-2, Ln. 26, Mineyuan 1st Rd.
Lingya District
Kaohsiung City,  TW 802
Applicant Contact UTA SHIH
Correspondent
Sigma Medical Supplies Corp.
15f-2, Ln. 26, Mineyuan 1st Rd.
Lingya District
Kaohsiung City,  TW 802
Correspondent Contact UTA SHIH
Regulation Number880.6850
Classification Product Code
FRG  
Date Received12/18/2013
Decision Date 03/11/2015
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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