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510(k) K813224

CERAVITAL CERAMIC EAR CANAL WALL PROSTH by Xomed, Inc. — Product Code ESF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1982
Date Received
November 9, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent
Device Class
Class II
Regulation Number
878.3500
Review Panel
SU
Submission Type

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  • K002828 — XPS NITRO SYSTEM (October 17, 2000)
  • K002897 — TITANIUM MIDDLE EAR PROSTHESES (October 11, 2000)
  • K993653 — MICRO-FRANCE TROCARS AND ACCESSORIES (June 9, 2000)
  • K001148 — MEROGEL OTOLOGIC PACK (June 3, 2000)
  • K994262 — FRONTAL SINUS TREPHINATION CANNULA (February 8, 2000)
  • K992855 — XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT (January 21, 2000)
  • K993582 — MODIFICATION TO LASER-SHIELD II (January 20, 2000)
  • K993655 — MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS (December 21, 1999)

Other clearances for product code ESF

  • K891247 — BEHIND-THE-EAR HEARING AID MODEL 404 PP-PC (March 29, 1989)