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510(k) K062540

Device
NASOPORE EAR, MODELS ND04, ND05
Applicant
Polyganics BV
510(k) number
K062540
Product code
KCN  
Decision
Substantially Equivalent (SESE)
Decision date
2006-10-18
Date received
2006-08-30
Regulation
874.5220
Classification name
Ear Wick
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JAN NIEUWENHUIS
Address
L.J. Zielstraweg 1 Groningen NL 9713-GX 9713-GX

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KCN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K973578INVOTEC EAR TAMPON (WICK) W/STRINGInvotec International, Inc.1997-11-06
K920357ULTRACELL EAR WICKUltracell Medical Technologies, Inc.1993-02-01
K791059POPE OTO-WICK, STERILE & NON-STERILEXomed, Inc.1979-07-17

Legacy Summary#

summary

FDA Review#

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