Name: Predicase
Price: 199 USD

K-number	K934610
Device name	CATH DOME PD- WATER RESISTANT COVER FOR INDWELLING PERITONEAL DIALYSIS CATHETERS AND TRANSFER SETS
Applicant	Tabex Industries, Inc.
Product code	FJS
Device class	Class II
Decision date	Sep 23, 1994
Decision	Substantially Equivalent
Regulation	876.5630

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Source

View the full FDA submission: accessdata.fda.gov

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CATH DOME PD- WATER RESISTANT COVER FOR INDWELLING PERITONEAL DIALYSIS CATHETERS AND TRANSFER SETS

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