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510(k) K902685

DEFIANCE MODEL FUS 336 by Defiance Electronics, Inc. — Product Code EAZ

K902685 is an FDA 510(k) premarket notification submitted by Defiance Electronics, Inc. for the device "DEFIANCE MODEL FUS 336". The FDA issued a decision of Substantially Equivalent on September 17, 1990. The device falls under product code EAZ (Light, Operating, Dental), a Class I device regulated under 21 CFR 872.4630. Defiance Electronics, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1990
Date Received
June 19, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Operating, Dental
Device Class
Class I
Regulation Number
872.4630
Review Panel
DE
Submission Type

Other clearances by Defiance Electronics, Inc.

  • K934815 — AIR COMPRESSOR, MODEL PAC 6.7 (February 1, 1994)

Other clearances for product code EAZ

  • K072309 — MICROLUX/BLU (November 19, 2007)
  • K041614 — MICROLUX DL (April 4, 2005)
  • K033033 — VIZILITE-BLUE ORAL EXAM KIT (November 22, 2004)
  • K003995 — SPECULITE/ORALLITE (March 16, 2001)
  • K926081 — DENTAL LIGHT (January 26, 1994)
  • K935390 — SIROLUX FANTASTIC (December 10, 1993)
  • K925629 — ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT (November 23, 1993)
  • K923462 — DELIGHT (December 21, 1992)
  • K912142 — MICRONAIRE ISO-HOOD MAX 5UV (October 30, 1991)
  • K912997 — MINIFLEX AND PERSONAL UNIT (October 30, 1991)

FDA data resources