Name: Predicase
Price: 199 USD

K-number	K091833
Device name	GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE.
Applicant	Gemore Technology Co, Ltd.
Product code	NGX
Device class	Class II
Decision date	Oct 16, 2009
Decision	Substantially Equivalent
Regulation	890.5850

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Source

View the full FDA submission: accessdata.fda.gov

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GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE.

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