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FDA 510(k)

MICRO-PLANER HANDPIECE

K-Number: K954715 · 1995-10-27

ApplicantTrebay Medical Corp.
Decision Date1995-10-27
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MICRO-PLANER HANDPIECE 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 1995-10-27 under 510(k) number K954715. 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 MICRO-PLANER HANDPIECE?

MICRO-PLANER HANDPIECE is a medical device that received FDA 510(k) clearance on 1995-10-27. The listed applicant is Trebay Medical Corp.. The 510(k) number is K954715.

When did MICRO-PLANER HANDPIECE receive FDA 510(k) clearance?

MICRO-PLANER HANDPIECE received FDA 510(k) clearance on 1995-10-27, under 510(k) number K954715.

Who is the listed applicant for MICRO-PLANER HANDPIECE?

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 MICRO-PLANER HANDPIECE?

The FDA product code for MICRO-PLANER HANDPIECE is ERL.

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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 SYSTEMK955294SOF - ABRASION BURK955560TREBAY SCOPE IRRIGATED CLEARING SLEEVEK955447TYMPANOSTOMY TUBEK954912TREBAY IRRIGATED CUTTER BLADE (MODIFICATION)K954795AT2 & DOYLE STYLE (C-FLEX) VENT TUBES

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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

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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