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FDA 510(k)

INVOTEC EAR TAMPON (WICK) W/STRING

K-Number: K973578 · 1997-11-06

ApplicantInvotec International, Inc.
Decision Date1997-11-06
Product CodeKCN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

INVOTEC EAR TAMPON (WICK) W/STRING is the device name listed in this FDA 510(k) record. The listed applicant is Invotec International, Inc.. It received FDA 510(k) clearance on 1997-11-06 under 510(k) number K973578. The device is classified under product code KCN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INVOTEC EAR TAMPON (WICK) W/STRING?

INVOTEC EAR TAMPON (WICK) W/STRING is a medical device that received FDA 510(k) clearance on 1997-11-06. The listed applicant is Invotec International, Inc.. The 510(k) number is K973578.

When did INVOTEC EAR TAMPON (WICK) W/STRING receive FDA 510(k) clearance?

INVOTEC EAR TAMPON (WICK) W/STRING received FDA 510(k) clearance on 1997-11-06, under 510(k) number K973578.

Who is the listed applicant for INVOTEC EAR TAMPON (WICK) W/STRING?

The FDA 510(k) record lists Invotec International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INVOTEC EAR TAMPON (WICK) W/STRING?

The FDA product code for INVOTEC EAR TAMPON (WICK) W/STRING is KCN.

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Other records listing Invotec International, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K122040INVOTEC LARYNGEAL ELECTRODEK080740CLEARVIEW ENDOSCOPE COVERK030492TITANIUM OSSICULAR REPLACMENT SYSTEMK973580INVOTEC CLEAN PADK971000EPISTAXIS NASAL PACKK930114TRACHEOSTOMY T-TUBE

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Related Devices (Code: KCN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K062540NASOPORE EAR, MODELS ND04, ND05Polyganics B.V.,K920357ULTRACELL EAR WICKUltracell Medical Technologies, Inc.K791059POPE OTO-WICK, STERILE & NON-STERILEXomed, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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