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510(k) K802870

RION ELECTRO-PALATOGRAPH MODEL DP-01 by Kindel & Anderson — Product Code LEZ

K802870 is an FDA 510(k) premarket notification submitted by Kindel & Anderson for the device "RION ELECTRO-PALATOGRAPH MODEL DP-01". The FDA issued a decision of Substantially Equivalent on December 17, 1980. The device falls under product code LEZ (Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact)), a Class U device. Kindel & Anderson has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1980
Date Received
November 14, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact)
Device Class
Class U
Regulation Number
Review Panel
EN
Submission Type

Other clearances by Kindel & Anderson

  • K823384 — HEARING AID HB-72 RIONET (December 9, 1982)
  • K823383 — HEARING AID HB-33 RIONET (December 9, 1982)
  • K802812 — RIONET HEARING AID (November 26, 1980)

Other clearances for product code LEZ

  • K091682 — LSVT C OR LSVT COMPANION, MODEL V.1 (August 20, 2009)
  • K982396 — VISIVOX, MODEL V-2 (September 14, 1998)

FDA data resources