510(k) K905437

RIVER MEDICAL MICRODRILL SYSTEM by River Medical, Inc. — Product Code EQH

K905437 is an FDA 510(k) premarket notification submitted by River Medical, Inc. for the device "RIVER MEDICAL MICRODRILL SYSTEM". The FDA issued a decision of Substantially Equivalent on May 30, 1991. The device falls under product code EQH (Source, Carrier, Fiberoptic Light), a Class I device regulated under 21 CFR 874.4350. River Medical, Inc. has at least 10 other 510(k) clearances on record.