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510(k) K851441

TACTICON 1600 by Medecon — Product Code LRA

K851441 is an FDA 510(k) premarket notification submitted by Medecon for the device "TACTICON 1600". The FDA issued a decision of Substantially Equivalent on June 27, 1985. The device falls under product code LRA (Hearing Aid, Tactile), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1985
Date Received
April 10, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hearing Aid, Tactile
Device Class
Class U
Regulation Number
Review Panel
EN
Submission Type

Other clearances for product code LRA

  • K883853 — ETA (November 17, 1988)
  • K862471 — WEARABLE TWENTY-FOUR CHANNEL VIBROTACTILE VOCODER (September 12, 1986)
  • K851655 — TEACHER TM (June 20, 1985)
  • K843433 — KANIEVSKI SENSORY AID OR DEVICE (November 14, 1984)
  • K831501 — TACTIL EAR (August 26, 1983)
  • K830418 — TACTAID (March 10, 1983)
  • K813057 — VIBRO-COM COMMUNICATOR #8827 (December 2, 1981)

FDA data resources