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FDA 510(k)

COLLAR BUTTON VENT TUBE

K-Number: K830085 · 1983-01-28

ApplicantTreace Medical, Inc.
Decision Date1983-01-28
Product CodeETD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

COLLAR BUTTON VENT TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Treace Medical, Inc.. It received FDA 510(k) clearance on 1983-01-28 under 510(k) number K830085. The device is classified under product code ETD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLLAR BUTTON VENT TUBE?

COLLAR BUTTON VENT TUBE is a medical device that received FDA 510(k) clearance on 1983-01-28. The listed applicant is Treace Medical, Inc.. The 510(k) number is K830085.

When did COLLAR BUTTON VENT TUBE receive FDA 510(k) clearance?

COLLAR BUTTON VENT TUBE received FDA 510(k) clearance on 1983-01-28, under 510(k) number K830085.

Who is the listed applicant for COLLAR BUTTON VENT TUBE?

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

What is the FDA product code for COLLAR BUTTON VENT TUBE?

The FDA product code for COLLAR BUTTON VENT TUBE is ETD.

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Other records listing Treace Medical, 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.

K883727BUCKET PROSTHESIS PORPK882349MALLET, SURGICALK874779BIPOLATOR 50K873154TREACE MAGNUM OTO-TOOL SYSTEMK872000EYE GARDK870765CANNULATED INSTRUMENT CLEANERS

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Related Devices (Code: ETD)

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.

K252436Tula Tympanostomy Tube Delivery DeviceTusker Medical, Inc.K250256Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000))Aventamed DacK232702Solo+ Tympanostomy Tube Device (TTD)Aventamed DacK233658Biowy Tym Tube (TT)Biowy CorporationK232059Tympanostomy TubesGrace Medical, Inc.K221254Hummingbird Tympanostomy Tube SystemPreceptis Medical, 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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