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510(k) K905576

LINGRAPHICA VISUAL LANGUAGE PROSTHESIS by Tolfa Corp. — Product Code ILQ

K905576 is an FDA 510(k) premarket notification submitted by Tolfa Corp. for the device "LINGRAPHICA VISUAL LANGUAGE PROSTHESIS". The FDA issued a decision of Substantially Equivalent on December 31, 1990. The device falls under product code ILQ (System, Communication, Powered), a Class II device regulated under 21 CFR 890.3710.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 1990
Date Received
December 12, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Communication, Powered
Device Class
Class II
Regulation Number
890.3710
Review Panel
PM
Submission Type

Other clearances for product code ILQ

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  • K943035 — P.A.T. SYSTEM (October 4, 1994)
  • K930044 — COMFORT KEYBOARD SYSTEM (July 14, 1994)
  • K931855 — LIGHTWRITER (May 10, 1994)
  • K935244 — R & D BATTERIES, INC. PART NUMBER 5113 (April 19, 1994)
  • K935981 — MLT-2 (February 17, 1994)
  • K925387 — LIBERATOR (March 29, 1993)
  • K925527 — LIGHT TALKER (March 22, 1993)
  • K924014 — SECRETARY (March 4, 1993)
  • K924030 — SCRIBE (March 4, 1993)

FDA data resources