K-number	K211204
Device name	SafePort(TM) Manifold (or Stopcock)
Applicant	Elcam Medical Acal
Product code	FMG
Device class	Class II
Decision date	Sep 15, 2022
Decision	Substantially Equivalent
Regulation	880.5440

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Source

View the full FDA submission: accessdata.fda.gov

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SafePort(TM) Manifold (or Stopcock)

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