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510(k) K844002

HU-FRIEDY IMS CASSETTE SYSTEM by Hu-Friedy Mfg. Co., Inc. — Product Code FSM

K844002 is an FDA 510(k) premarket notification submitted by Hu-Friedy Mfg. Co., Inc. for the device "HU-FRIEDY IMS CASSETTE SYSTEM". The FDA issued a decision of Substantially Equivalent on November 8, 1984. The device falls under product code FSM (Tray, Surgical, Instrument), a Class I device regulated under 21 CFR 878.4800. Hu-Friedy Mfg. Co., Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1984
Date Received
October 12, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Surgical, Instrument
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Hu-Friedy Mfg. Co., Inc.

  • K120659 — HU-FRIEDY DENTAL CARTRIDGE SYRINGE (November 6, 2012)
  • K100401 — SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM (March 30, 2010)
  • K073369 — EI DOWNPAK BARRIER SLEEVES (February 27, 2008)
  • K070975 — SYMMETRY IQ, MODEL 2000 SERIES, 3000 SERIES (June 21, 2007)
  • K053178 — SYMMETRY S-SERIES PIEZOELECTRIC SCALING TIPS (February 1, 2006)
  • K012060 — MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSERT (July 27, 2001)
  • K953919 — DENTAL ULTRASONIC SCALER INSERTS (October 7, 1995)
  • K912473 — ACCU-PLACER TM KIT (July 24, 1991)

Other clearances for product code FSM

  • K971217 — INSTRUMENT TRAY LINER (May 6, 1997)
  • K962328 — SINGLE USE INSTRUMENT TRAY (August 9, 1996)
  • K944025 — SURGICAL INSTRUMENT TRAY (November 22, 1994)
  • K912106 — ARTHROSCOPY TRAY (August 29, 1991)
  • K912053 — OPEN HEART TRAY (August 26, 1991)
  • K912052 — HEART CATH TRAY (August 20, 1991)
  • K912104 — MAJOR BASIN TRAY (August 9, 1991)
  • K910570 — SPLINTER TWEEZERS (May 31, 1991)
  • K911601 — REDDICK TROCAR AND CANNULA (May 21, 1991)
  • K910328 — KEY COMFORT GRIPS (March 6, 1991)

FDA data resources