Name: Predicase
Price: 199 USD

K-number	K072256
Device name	HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM WITH OPTIONAL HANDS-FREE OPERATION, MODEL
Applicant	Hill Laboratories Co.
Product code	PFW
Device class	Class II
Decision date	Mar 12, 2008
Decision	Substantially Equivalent
Regulation	890.5300

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Source

View the full FDA submission: accessdata.fda.gov

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HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM WITH OPTIONAL HANDS-FREE OPERATION, MODEL

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