Name: Predicase
Price: 199 USD

K-number	K162161
Device name	Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit
Applicant	Stimwave Technologies Incorporated
Product code	GZB
Device class	Class II
Decision date	Dec 16, 2016
Decision	Substantially Equivalent
Regulation	882.5880

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Source

View the full FDA submission: accessdata.fda.gov

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Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit

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