Name: Predicase
Price: 199 USD

K-number	K993189
Device name	CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBING
Applicant	Terumo Corp.
Product code	DWE
Device class	Class II
Decision date	Mar 1, 2000
Decision	Substantially Equivalent
Regulation	870.4390

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Source

View the full FDA submission: accessdata.fda.gov

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CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBING

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