Name: Predicase
Price: 199 USD

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
Product code	FRG
Device class	Class II
Decision date	Nov 18, 2016
Decision	Substantially Equivalent
Regulation	880.6850

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Source

View the full FDA submission: accessdata.fda.gov

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PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator

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