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510(k) K822411

SYSTEM 80 FACEPLATE-IN-THE-EAR #F1 by Western Advanced Technology, Inc. — Product Code EIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 1983
Date Received
August 10, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Irrigating (Dental)
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Western Advanced Technology, Inc.

  • K813557 — AUDITORY STIMULATOR (January 19, 1982)
  • K812138 — TENS DEVICE (August 20, 1981)
  • K811790 — OCTOTOXIC SCREENER (July 15, 1981)
  • K811772 — AUDITORY LOCALIZER (July 15, 1981)
  • K802324 — E1 SERIES HEARING AID (October 10, 1980)

Other clearances for product code EIB

  • K911118 — DTF-1000LL,DTF-1000 (November 20, 1991)
  • K874543 — MODEL OPO-32 IRRIGATION SLEEVE (January 14, 1988)
  • K760570 — ROBINSON MIDDLE EAR PROSTHESIS (September 21, 1976)