Name: Predicase
Price: 199 USD

K-number	K970088
Device name	RIWO DRIVE WITH FOOTSWITCH/MOTOR HANDLE, COOMPLETE,6000RPM/3000RPM/ROTARY BLADES AND ABRADERS SEE SECTION 1:
Applicant	Richard Wolf Medical Instruments Corp.
Product code	HWE
Device class	Class I
Decision date	Apr 7, 1997
Decision	Substantially Equivalent
Regulation	878.4820

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Source

View the full FDA submission: accessdata.fda.gov

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RIWO DRIVE WITH FOOTSWITCH/MOTOR HANDLE, COOMPLETE,6000RPM/3000RPM/ROTARY BLADES AND ABRADERS SEE SECTION 1:

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