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FDA 510(k)

MICRO FLUID APPLICATOR

K-Number: K841357 · 1984-08-24

ApplicantTreace Medical, Inc.
Decision Date1984-08-24
Product CodeJZF
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MICRO FLUID APPLICATOR 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 1984-08-24 under 510(k) number K841357. The device is classified under product code JZF. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRO FLUID APPLICATOR?

MICRO FLUID APPLICATOR is a medical device that received FDA 510(k) clearance on 1984-08-24. The listed applicant is Treace Medical, Inc.. The 510(k) number is K841357.

When did MICRO FLUID APPLICATOR receive FDA 510(k) clearance?

MICRO FLUID APPLICATOR received FDA 510(k) clearance on 1984-08-24, under 510(k) number K841357.

Who is the listed applicant for MICRO FLUID APPLICATOR?

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 MICRO FLUID APPLICATOR?

The FDA product code for MICRO FLUID APPLICATOR is JZF.

Related Clinical Trials

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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: JZF)

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.

K973587EXMOOR TYMPANOCENTESIS KIT (TK/1)Exmoor Plastics , Ltd.K862903MIDDLE EAR VIEWER AND FLUID COLLECTORSteven K. JuhnK853589SHAH SELF-CLEARING MASTOID SUCTION TUBEDowns Surgical , Ltd.K822010RIGID SUCTION TIPS & RELATED ITEMSKelleher Corp.

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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