Name: Predicase
Price: 199 USD

K-number	K993772
Device name	X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR
Applicant	Terumo Medical Corp.
Product code	DTZ
Device class	Class II
Decision date	Jun 5, 2000
Decision	Substantially Equivalent
Regulation	870.4350

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Source

View the full FDA submission: accessdata.fda.gov

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X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR

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