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510(k) K003567

SERENOCEM, MODEL BC 010 by Corinthian Medical , Ltd. — Product Code NEA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2001
Date Received
November 20, 2000
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)
  • 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)