Name: Predicase
Price: 199 USD

K-number	K003927
Device name	Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02
Applicant	Cheen Houng Ent. Co. , Ltd.
Product code	BTM
Device class	Class II
Decision date	Jun 26, 2001
Decision	Substantially Equivalent
Regulation	868.5915

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Source

View the full FDA submission: accessdata.fda.gov

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Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02

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