Name: Predicase
Price: 199 USD

K-number	K103321
Device name	DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES
Applicant	Dana Products, Inc.
Product code	FRC
Device class	Class II
Decision date	Feb 16, 2011
Decision	Substantially Equivalent
Regulation	880.2800

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Source

View the full FDA submission: accessdata.fda.gov

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DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES

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