Name: Predicase
Price: 199 USD

K-number	K112591
Device name	SAFE SECURE STERILIZATION POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS INDICATORS
Applicant	Safe Secure Packaging Co., Ltd.
Product code	FRG
Device class	Class II
Decision date	Feb 7, 2012
Decision	Substantially Equivalent
Regulation	880.6850

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Source

View the full FDA submission: accessdata.fda.gov

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SAFE SECURE STERILIZATION POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS INDICATORS

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