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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 K160595
Device Name PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator
Applicant
Pms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti
Karaduvar Mah.Serbest Bolge, 11.Cad #46
Mersin Serbest Bolgesi, Akdeniz
Mersin,  TR 33020
Applicant Contact Derya Dikici
Correspondent
Pms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti
Karaduvar Mah.Serbest Bolge, 11.Cad #46
Mersin Serbest Bolgesi, Akdeniz
Mersin,  TR 33020
Correspondent Contact Derya Dikici
Regulation Number880.6850
Classification Product Code
FRG  
Subsequent Product Code
JOJ  
Date Received03/01/2016
Decision Date 11/18/2016
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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