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FDA 510(k)

SHEA MIDDLE EAR MICRODRILL

K-Number: K833874 · 1984-06-22

ApplicantApplied Research Corp.
Decision Date1984-06-22
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SHEA MIDDLE EAR MICRODRILL is the device name listed in this FDA 510(k) record. The listed applicant is Applied Research Corp.. It received FDA 510(k) clearance on 1984-06-22 under 510(k) number K833874. The device is classified under product code ERL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHEA MIDDLE EAR MICRODRILL?

SHEA MIDDLE EAR MICRODRILL is a medical device that received FDA 510(k) clearance on 1984-06-22. The listed applicant is Applied Research Corp.. The 510(k) number is K833874.

When did SHEA MIDDLE EAR MICRODRILL receive FDA 510(k) clearance?

SHEA MIDDLE EAR MICRODRILL received FDA 510(k) clearance on 1984-06-22, under 510(k) number K833874.

Who is the listed applicant for SHEA MIDDLE EAR MICRODRILL?

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

What is the FDA product code for SHEA MIDDLE EAR MICRODRILL?

The FDA product code for SHEA MIDDLE EAR MICRODRILL is ERL.

Related Clinical Trials

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.

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Other records listing Applied Research 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.

K833875SHEA FOOTPLATE MICRODRILL

Related Devices (Code: ERL)

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.

K243280Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)W&H Dentalwerk Buermoos GmbHK233958hekaDrillZethon, Ltd.K221184ORiGO SystemBien-Air Surgery SAK213221AMADEO, M-UK1015 (incl. attachments and accessories)W&H Dentalwerk Buermoss GmbHK212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.K211490Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000Stryker Corporation

Official Source

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

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