Name: Predicase
Price: 199 USD

K-number	K092745
Device name	VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR ETHYLENE OXIDE, MODELS: SELF AND HEAT SEAL POUCHES, HEAT SEAL TU
Applicant	STERIS Corporation
Product code	KCT
Device class	Class II
Decision date	Nov 19, 2010
Decision	Substantially Equivalent
Regulation	880.6850

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View the full FDA submission: accessdata.fda.gov

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VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR ETHYLENE OXIDE, MODELS: SELF AND HEAT SEAL POUCHES, HEAT SEAL TU

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