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510(k) K973578

Device
INVOTEC EAR TAMPON (WICK) W/STRING
Applicant
INVOTEC INTERNATIONAL, INC.
510(k) number
K973578
Product code
KCN  
Decision
Substantially Equivalent (SESE)
Decision date
1997-11-06
Date received
1997-09-19
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
Statement
Third party reviewed
No

Applicant Contact#

Contact
JEFFREY L AULL
Address
11243-1 St. Johns Industrial Pkwy. S. Jacksonville FL US 32246 32246

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KCN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K062540NASOPORE EAR, MODELS ND04, ND05Polyganics B.V.,2006-10-18
K920357ULTRACELL EAR WICKUltracell Medical Technologies, Inc.1993-02-01
K791059POPE OTO-WICK, STERILE & NON-STERILEXomed, Inc.1979-07-17

Legacy Summary#

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FDA Review#

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