Name: Predicase
Price: 199 USD

K-number	K952823
Device name	FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE
Applicant	Icor AB
Product code	BYD
Device class	Class I
Decision date	Jul 13, 1995
Decision	Substantially Equivalent
Regulation	868.5375

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Source

View the full FDA submission: accessdata.fda.gov

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FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE

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