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FDA 510(k)

OTOTOME BUR

K-Number: K792028 · 1979-10-26

ApplicantAmerican Sterilizer Co.
Decision Date1979-10-26
Product CodeEQJ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OTOTOME BUR is the device name listed in this FDA 510(k) record. The listed applicant is American Sterilizer Co.. It received FDA 510(k) clearance on 1979-10-26 under 510(k) number K792028. 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 OTOTOME BUR?

OTOTOME BUR is a medical device that received FDA 510(k) clearance on 1979-10-26. The listed applicant is American Sterilizer Co.. The 510(k) number is K792028.

When did OTOTOME BUR receive FDA 510(k) clearance?

OTOTOME BUR received FDA 510(k) clearance on 1979-10-26, under 510(k) number K792028.

Who is the listed applicant for OTOTOME BUR?

The FDA 510(k) record lists American Sterilizer Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OTOTOME BUR?

The FDA product code for OTOTOME BUR is EQJ.

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Other records listing American Sterilizer Co. 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.

K943288AMSCO SQ240 SURGICAL LIGHTK931872THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZERK922485CHEMDI-VHP CHEMICAL INDICATORK930493QUANTUM 3080 SURGICAL TABLEK905816ORTHOVISION TABLEK896674AMSCO QUANTUM LIGHT

View all 36 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.K955294SOF - ABRASION BURTrebay 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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