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510(k) K811698

CARL ZEISS INN MYRINGOTOMY TUBE LINE by James L. Geraci & Associates, Inc. — Product Code ETD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 1981
Date Received
June 16, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tympanostomy
Device Class
Class II
Regulation Number
874.3880
Review Panel
EN
Submission Type

Other clearances by James L. Geraci & Associates, Inc.

  • K853927 — LASE SYSTEM II (October 16, 1985)
  • K820091 — AIRMED SMOKE EVACUATION & FILTER (February 24, 1982)
  • K820079 — AIRMED PNEUMATIC EQUIP. FILTRA/CONTROL (February 5, 1982)
  • K820078 — DRAPE, SURGICAL (February 4, 1982)

Other clearances for product code ETD

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  • K232702 — Solo+ Tympanostomy Tube Device (TTD) (May 20, 2024)
  • K233658 — Biowy Tym Tube (TT) (February 16, 2024)
  • K232059 — Tympanostomy Tubes (November 24, 2023)
  • K221254 — Hummingbird Tympanostomy Tube System (July 27, 2022)
  • K200952 — Hummingbird Tympanostomy Tube System (June 5, 2020)
  • K171239 — TULA Tube Delivery System (June 28, 2017)
  • K151830 — Hummingbird Tympanostomy Tube (September 21, 2015)
  • K151067 — Ventilation (Tympanostomy) Tubes (July 22, 2015)
  • K142282 — HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS) (April 23, 2015)