Name: Predicase
Price: 199 USD

K-number	K042667
Device name	SEEDNET GOLD WITH RENAL KIT, MODEL FPRPR 3021, (RENAL KIT), FPRCH 2024 (SEEDNETGOLD)
Applicant	Galil Medical , Ltd.
Product code	GEH
Device class	Class II
Decision date	Oct 14, 2004
Decision	Substantially Equivalent
Regulation	878.4350

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Source

View the full FDA submission: accessdata.fda.gov

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SEEDNET GOLD WITH RENAL KIT, MODEL FPRPR 3021, (RENAL KIT), FPRCH 2024 (SEEDNETGOLD)

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