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510(k) K140644

PROCEM by Ototronix, LLC — Product Code NEA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 2014
Date Received
March 13, 2014
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 by Ototronix, LLC

  • K130201 — NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM (April 26, 2013)

Other clearances for product code NEA

  • K080032 — ENVOYCEM, MODEL 1640 (February 28, 2008)
  • 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)