Name: Predicase
Price: 199 USD

K-number	K001287
Device name	EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML
Applicant	Sorenson Medical, Inc.
Product code	KPE
Device class	Class II
Decision date	Jun 9, 2000
Decision	Substantially Equivalent
Regulation	880.5025

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML

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