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510(k) K832540

DRUMTO STAPES PROSTHESIS by Humboldt Products — Product Code ETB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1984
Date Received
July 29, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Partial Ossicular Replacement
Device Class
Class II
Regulation Number
874.3450
Review Panel
EN
Submission Type

Other clearances by Humboldt Products

  • K823483 — STAINLESS STEEL PISTONS (December 9, 1982)
  • K813616 — TEKNA MED MYRINGOTOMY DISPOS-OTO KIT (January 22, 1982)
  • K812562 — SURGICAL RETRACTOR & ELASTIC STAYS, DISP (October 2, 1981)
  • K802587 — OTOLOGICAL VENTILATION TUBES (November 12, 1980)

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