Name: Predicase
Price: 199 USD

K-number	K101858
Device name	PEDIATRIC HEAD-SPINE COIL (MODEL:5000012701
Applicant	Shanghai Chenguang Medical Technologies Co, Ltd.
Product code	MOS
Device class	Class II
Decision date	Jul 14, 2010
Decision	Substantially Equivalent
Regulation	892.1000

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Source

View the full FDA submission: accessdata.fda.gov

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PEDIATRIC HEAD-SPINE COIL (MODEL:5000012701

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