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FDA 510(k)

MICROTEK PISTON & WIRE PROSTHESES

K-Number: K895814 · 1989-12-26

ApplicantMicrobio-Medics, Inc.
Decision Date1989-12-26
Product CodeETB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MICROTEK PISTON & WIRE PROSTHESES is the device name listed in this FDA 510(k) record. The listed applicant is Microbio-Medics, Inc.. It received FDA 510(k) clearance on 1989-12-26 under 510(k) number K895814. The device is classified under product code ETB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROTEK PISTON & WIRE PROSTHESES?

MICROTEK PISTON & WIRE PROSTHESES is a medical device that received FDA 510(k) clearance on 1989-12-26. The listed applicant is Microbio-Medics, Inc.. The 510(k) number is K895814.

When did MICROTEK PISTON & WIRE PROSTHESES receive FDA 510(k) clearance?

MICROTEK PISTON & WIRE PROSTHESES received FDA 510(k) clearance on 1989-12-26, under 510(k) number K895814.

Who is the listed applicant for MICROTEK PISTON & WIRE PROSTHESES?

The FDA 510(k) record lists Microbio-Medics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROTEK PISTON & WIRE PROSTHESES?

The FDA product code for MICROTEK PISTON & WIRE PROSTHESES is ETB.

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Other records listing Microbio-Medics, Inc. as applicant

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K923353VENTILATION TUBES W/ HYDROGEL COATINGK922572321Q MINIMUM ENERGY TINNITUS SUPPRESSORK913276MICROTEK MEDICAL'S SOUND STIKSK904239SOFT HYDROXYLAPATITE OSSICULAR MALLEABLE PROSTHESK910167MICROTEK-HERITAGES SILICONE BULB EVACUATION SYSTEMK900726MICROTEK MEDICAL'S BLOOD COLLECTION KIT

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Related Devices (Code: ETB)

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.

K260718mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850)MED-EL Elektromedizinische Geräte GmbHK260720mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING Stapes Prosthesis (0.4 x 4.00 mm) (58721); mWING Stapes Prosthesis (0.4 x 4.25 mm) (58723); mWING Stapes Prosthesis (0.4 x 4.50 mm) (58725); mWING Stapes Prosthesis (0.4 x 4.75 mm) (58727); mWING Stapes Prosthesis (0.4 x 5.00 mm) (58729); mWING Stapes Prosthesis (0.4 x 5.25 mm) (58731); mWING Stapes Prosthesis (0.4 x 5.50 mm) (58733); mWING Stapes Prosthesis (0.5 x 3.50 mm) (58735);MED-EL Elektromedizinische Geräte GmbHK241261mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis KitMED-EL Elektromedizinische Geräte GmbHK241142mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes ProsthesisMED-EL Elektromedizinische Geräte GmbHK130512NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESISHeinz Kurz GmbH MedizintechnikK112616NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESISHeinz Kurz GmbH Medizintechnik

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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