Name: Predicase
Price: 199 USD

K-number	K925161
Device name	NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO
Applicant	North American Sterilization & Packaging Co.
Product code	KNY
Device class	Class II
Decision date	Jul 21, 1993
Decision	Substantially Equivalent
Regulation	876.5130

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Source

View the full FDA submission: accessdata.fda.gov

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NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO

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