Name: Predicase
Price: 199 USD

K-number	K970838
Device name	SOMNUS MODEL 30XX DISPOSABLE TRI-NEEDLE COAGULATING ELECTRODE
Applicant	Somnus Medical Technologies, Inc.
Product code	GEI
Device class	Class II
Decision date	Jan 9, 1998
Decision	Substantially Equivalent
Regulation	878.4400

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Source

View the full FDA submission: accessdata.fda.gov

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SOMNUS MODEL 30XX DISPOSABLE TRI-NEEDLE COAGULATING ELECTRODE

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