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510(k) K973578

INVOTEC EAR TAMPON (WICK) W/STRING by Invotec International, Inc. — Product Code KCN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 1997
Date Received
September 19, 1997
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

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  • K911040 — INVOTEC MICROSCOPE DRAPE (June 3, 1991)
  • K911039 — INVOTEC EAR DRAPE (May 13, 1991)
  • K901923 — INVOTEC POLY-MESH MANDIBULAR TRAY (October 31, 1990)

Other clearances for product code KCN

  • K062540 — NASOPORE EAR, MODELS ND04, ND05 (October 18, 2006)
  • K920357 — ULTRACELL EAR WICK (February 1, 1993)
  • K791059 — POPE OTO-WICK, STERILE & NON-STERILE (July 17, 1979)