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510(k) K936275

TYMPOVENT by Atos Medical AB — Product Code ETD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1994
Date Received
December 30, 1993
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

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Other clearances for product code ETD

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  • K171239 — TULA Tube Delivery System (June 28, 2017)
  • K151830 — Hummingbird Tympanostomy Tube (September 21, 2015)
  • K151067 — Ventilation (Tympanostomy) Tubes (July 22, 2015)
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