Name: Predicase
Price: 199 USD

K-number	K162362
Device name	PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator
Applicant	Pms Tibbi Cihazlar Teknolojisi San VE Tic AS
Product code	FRG
Device class	Class II
Decision date	Oct 13, 2017
Decision	Substantially Equivalent
Regulation	880.6850

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Source

View the full FDA submission: accessdata.fda.gov

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PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator

Everything you need for a 510(k) submission. Nothing you don't.