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510(k) K923887

JACK'S VENT TUBES by O.R. Specialties, Inc. — Product Code ETD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1993
Date Received
August 4, 1992
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 O.R. Specialties, Inc.

  • K942607 — LAPAROSCOPIC SCISSORS (DISPOSABLE) (July 6, 1994)
  • K923630 — PHACO NEEDLES 1000-R & 1000-O NEEDLES (April 6, 1994)
  • K925671 — DISPOSABLE SCLERAL PLUGS (August 2, 1993)
  • K923774 — DISPOSABLE ENDOILLUMINATOR (October 19, 1992)
  • K922355 — POLLY'S VITREOUS SCISSORS J-225-S (August 18, 1992)
  • K922180 — LEWICKY O.R.S. TUBING (July 2, 1992)
  • K914038 — POLLY'S CUTTER J-225 (December 9, 1991)
  • K911932 — J105 JAMES SURGICAL SYSTEM I/A PACK (August 26, 1991)
  • K890195 — JAMES SURGICAL SYSTEM J1000 (August 3, 1989)
  • K890825 — JUMPER PACK #203 (May 26, 1989)

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)