K-number	K102824
Device name	AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC
Applicant	Ambu A/S
Product code	BTM
Device class	Class II
Decision date	Jan 28, 2011
Decision	Substantially Equivalent
Regulation	868.5915

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View the full FDA submission: accessdata.fda.gov

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AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC

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