Name: Predicase
Price: 199 USD

K-number	K962604
Device name	PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZING
Applicant	Convatec, A Division of E.R. Squibb & Sons
Product code	FAQ
Device class	Class I
Decision date	Jul 18, 1996
Decision	Substantially Equivalent
Regulation	876.5250

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Source

View the full FDA submission: accessdata.fda.gov

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PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZING

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