Invotec Ear Tampon (Wick) W/String

FDA 510(k) K973578 · Invotec International, Inc.

Substantially Equivalent

510(k) numberK973578

Submission

Device name
Invotec Ear Tampon (Wick) W/String
Applicant
Invotec International, Inc.
Jacksonville, FL, US
Received
September 19, 1997
Decision date
November 6, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
KCN – Ear Wick
Device class
Class I (low risk)
Regulation
21 CFR 874.5220
Specialty
Ear, Nose, Throat

Other 510(k)s with product code KCN

510(k)DeviceApplicantDecision
K062540Nasopore Ear, Models ND04, ND05KCN · Traditional Polyganics B.V.,10/18/2006SE
K920357Ultracell Ear WickKCN · Traditional Ultracell Medical Technologies, Inc.02/01/1993SE
K791059Pope Oto-Wick, Sterile & Non-SterileKCN · Traditional Xomed, Inc.07/17/1979SE

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Questions and answers

When was Invotec Ear Tampon (Wick) W/String cleared by the FDA?

Invotec Ear Tampon (Wick) W/String (K973578) received a 510(k) decision of Substantially Equivalent on November 6, 1997, 48 days after the submission was received.

What is the product code of K973578?

The FDA product code is KCN – Ear Wick, a Class I (low risk) device regulated under 21 CFR 874.5220.