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510(k) K062540

NASOPORE EAR, MODELS ND04, ND05 by Polyganics B.V., — Product Code KCN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2006
Date Received
August 30, 2006
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 Polyganics B.V.,

  • K141816 — HEMOPORE (October 23, 2014)
  • K141423 — NASOPORE-FD (August 7, 2014)
  • K112267 — NEUROLAC(R) NERVE GUIDE (October 20, 2011)
  • K070715 — NASOPORE EAR (May 7, 2007)
  • K052099 — NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ (November 21, 2005)
  • K050573 — NEUROLAC NERVE GUIDE (May 4, 2005)
  • K042811 — VIVOSORB SHEET, MODEL FS01 (November 8, 2004)
  • K032115 — NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03 (October 10, 2003)

Other clearances for product code KCN

  • K973578 — INVOTEC EAR TAMPON (WICK) W/STRING (November 6, 1997)
  • K920357 — ULTRACELL EAR WICK (February 1, 1993)
  • K791059 — POPE OTO-WICK, STERILE & NON-STERILE (July 17, 1979)