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510(k) K840112

SPEECH TEACHER by Joseph A. Resnick — Product Code ILP

K840112 is an FDA 510(k) premarket notification submitted by Joseph A. Resnick for the device "SPEECH TEACHER". The FDA issued a decision of Substantially Equivalent on March 22, 1984. The device falls under product code ILP (System, Communication, Non-Powered), a Class I device regulated under 21 CFR 890.3700.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1984
Date Received
January 9, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Communication, Non-Powered
Device Class
Class I
Regulation Number
890.3700
Review Panel
PM
Submission Type

Other clearances for product code ILP

  • K844890 — TELL ME TAGS - NONPOWERED COMMUNICATION SYS (March 8, 1985)
  • K831546 — ADAPTIVE PENS & LAP DESK (June 8, 1983)
  • K823624 — HOLDER FOR MOUTH STICK (December 30, 1982)
  • K823612 — ADJ. WOODEN BOARD FOR WRITING (December 30, 1982)
  • K823608 — PICTURES & WORD IDENTIFICATION CVA PAT (December 30, 1982)
  • K823625 — MOUTH STICK KIT (December 30, 1982)
  • K823615 — TELEPHONE ADAPTOR-PERSONS CANT ANSWER (December 22, 1982)
  • K823616 — PLASTIC SLIP-ON PEN/PENCIL HOLDER (December 22, 1982)
  • K823617 — PLASTIC SLIP-ON POINTS W/RUBBER TIP FOR (December 22, 1982)
  • K823609 — KIT OF WORDS & LTRS TO RE-LEARN-BK4014 (December 22, 1982)

FDA data resources