Name: Predicase
Price: 199 USD

K-number	K042556
Device name	SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL SILICONE MANUAL RESUSCIATOR, ENT-1022,
Applicant	Enter Medical Corporation
Product code	BTM
Device class	Class II
Decision date	Mar 11, 2005
Decision	Substantially Equivalent
Regulation	868.5915

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Source

View the full FDA submission: accessdata.fda.gov

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SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL SILICONE MANUAL RESUSCIATOR, ENT-1022,

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