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510(k) K905437

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 1991
Date Received
December 4, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Carrier, Fiberoptic Light
Device Class
Class I
Regulation Number
874.4350
Review Panel
EN
Submission Type

Other clearances by River Medical, Inc.

  • K023174 — DISPOSABLE TEMPORARY PACING WIRE (June 11, 2003)
  • K944351 — SMARTDOSE IV PREFILLED INFUSION CONTAINER (November 15, 1995)
  • K944352 — SMARTDOSE III INFUSION CONTAINER (November 15, 1995)
  • K945298 — SMARTFLOW I ADMINISTRATION SET (June 14, 1995)
  • K943692 — SMART DOSE(TM) (April 28, 1995)
  • K932895 — RIVER PUMP (March 31, 1994)
  • K933335 — RIVER VIAL ADAPTER (March 1, 1994)
  • K915120 — TEF/PLATINUM PISTON (December 27, 1991)
  • K915121 — TEF/WIRE PISTON (December 23, 1991)
  • K913286 — H/A TOTAL-REGULAR, H/A TOTAL-OFFSET (December 18, 1991)

Other clearances for product code EQH

  • K945876 — WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT (December 4, 1995)
  • K954184 — JED-LIGHT FIBEROPTIC LIGHT SOURCE (November 13, 1995)
  • K951829 — COLD LIGHT SOURCE LOS 150 (July 10, 1995)
  • K932771 — BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE (August 24, 1994)
  • K941661 — GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT (August 23, 1994)
  • K941662 — GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT (July 20, 1994)
  • K934911 — SAPHIRE PLUS SURGICAL MIRROR (June 21, 1994)
  • K932131 — MID LABS TWIN ILLUMINATOR (April 1, 1994)
  • K930123 — ASPIRATING ENDO OCULAR PROBE (February 16, 1994)
  • K933145 — FIBEROPTIC LIGHTSOURCES AND CARRIERS (September 7, 1993)