Name: Predicase
Price: 199 USD

K-number	K021286
Device name	MICROSELECTRON HDR- GENIE AFTERLOADING SYSTEM, MODEL 105.989 FOR 115VOLT DEVICES AND 105.988 FOR 230VOLT DEVICES
Applicant	Nucletron Corp.
Product code	JAQ
Device class	Class II
Decision date	May 23, 2002
Decision	Substantially Equivalent
Regulation	892.5700

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Source

View the full FDA submission: accessdata.fda.gov

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MICROSELECTRON HDR- GENIE AFTERLOADING SYSTEM, MODEL 105.989 FOR 115VOLT DEVICES AND 105.988 FOR 230VOLT DEVICES

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