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FDA 510(k)

SOF - ABRASION BUR

K-Number: K955294 · 1995-12-22

ApplicantTrebay Medical Corp.
Decision Date1995-12-22
Product CodeEQJ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SOF - ABRASION BUR is the device name listed in this FDA 510(k) record. The listed applicant is Trebay Medical Corp.. It received FDA 510(k) clearance on 1995-12-22 under 510(k) number K955294. The device is classified under product code EQJ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOF - ABRASION BUR?

SOF - ABRASION BUR is a medical device that received FDA 510(k) clearance on 1995-12-22. The listed applicant is Trebay Medical Corp.. The 510(k) number is K955294.

When did SOF - ABRASION BUR receive FDA 510(k) clearance?

SOF - ABRASION BUR received FDA 510(k) clearance on 1995-12-22, under 510(k) number K955294.

Who is the listed applicant for SOF - ABRASION BUR?

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

What is the FDA product code for SOF - ABRASION BUR?

The FDA product code for SOF - ABRASION BUR is EQJ.

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Other records listing Trebay Medical Corp. 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.

K955704TREBAY MICRODEBRIDER SYSTEMK955560TREBAY SCOPE IRRIGATED CLEARING SLEEVEK955447TYMPANOSTOMY TUBEK954912TREBAY IRRIGATED CUTTER BLADE (MODIFICATION)K954795AT2 & DOYLE STYLE (C-FLEX) VENT TUBESK954796MICRO-INGRESSOR HANDIPIECE

View all 14 devices →

Related Devices (Code: EQJ)

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.

K161514Precision Thin Reciprocating Blade, 0.010in.Stryker CorporationK041985XPS CURVED BURMedtronic Xomed, Inc.K974232ESSENTIAL SHAVER SYSTEMGyrus Ent LLCK960853ACE SYSTEMXomed, Inc.K955704TREBAY MICRODEBRIDER SYSTEMTrebay Medical Corp.K954912TREBAY IRRIGATED CUTTER BLADE (MODIFICATION)Trebay Medical 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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