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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 K152669
Device Name PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP)
Applicant
Pms Tip Teknolojileri Sanayi VE Ticaret Limited Std
Mersin Tarsus Organize Sanayi Bolgesi 12, Cad #2 Huzurkent
Mersin,  TR 33020
Applicant Contact DERYA DIKICI
Correspondent
Pms Tip Teknolojileri Sanayi VE Ticaret Limited Std
Mersin Tarsus Organize Sanayi Bolgesi 12, Cad #2 Huzurkent
Mersin,  TR 33020
Correspondent Contact DERYA DIKICI
Regulation Number880.6850
Classification Product Code
FRG  
Subsequent Product Code
JOJ  
Date Received09/17/2015
Decision Date 01/15/2016
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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