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510(k) K791059

POPE OTO-WICK, STERILE & NON-STERILE by Xomed, Inc. — Product Code KCN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1979
Date Received
June 8, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ear Wick
Device Class
Class I
Regulation Number
874.5220
Review Panel
EN
Submission Type

Other clearances by Xomed, Inc.

  • K002395 — MODEL 30 CLASSIC PNEUMATONOMETER (December 11, 2000)
  • K002987 — REDTRONIC XOMED MONOPOLAR ENERGIZED BLADE (December 4, 2000)
  • 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 KCN

  • K062540 — NASOPORE EAR, MODELS ND04, ND05 (October 18, 2006)
  • K973578 — INVOTEC EAR TAMPON (WICK) W/STRING (November 6, 1997)
  • K920357 — ULTRACELL EAR WICK (February 1, 1993)