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510(k) K080032

ENVOYCEM, MODEL 1640 by Envoy Medical Corporation — Product Code NEA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2008
Date Received
January 7, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Ear, Nose And Throat
Device Class
Class II
Regulation Number
872.3275
Review Panel
EN
Submission Type

Other clearances for product code NEA

  • K140644 — PROCEM (June 19, 2014)
  • K060750 — STRYKER INJECTABLE CEMENT (April 19, 2006)
  • K042516 — OTOMIMIX (November 8, 2004)
  • K011338 — OTO-CEM (September 13, 2001)
  • K003567 — SERENOCEM, MODEL BC 010 (February 12, 2001)