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FDA 510(k)

POLY PISTON

K-Number: K945108 · 1994-11-22

ApplicantMicromed Development Corp.
Decision Date1994-11-22
Product CodeETB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

POLY PISTON is the device name listed in this FDA 510(k) record. The listed applicant is Micromed Development Corp.. It received FDA 510(k) clearance on 1994-11-22 under 510(k) number K945108. 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 POLY PISTON?

POLY PISTON is a medical device that received FDA 510(k) clearance on 1994-11-22. The listed applicant is Micromed Development Corp.. The 510(k) number is K945108.

When did POLY PISTON receive FDA 510(k) clearance?

POLY PISTON received FDA 510(k) clearance on 1994-11-22, under 510(k) number K945108.

Who is the listed applicant for POLY PISTON?

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

What is the FDA product code for POLY PISTON?

The FDA product code for POLY PISTON is ETB.

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Other records listing Micromed Development 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.

K945105POLY/PLATINUM WIRE PISTONK945831DISPOSABLE JOINT ASPIRATION/INJECTION DIAGNOSTIC KITK945242NERVE MONITOR ELECTRODES/STIMULATOR PROBESK945107POLY-WIRE PISTONK945438EDI-BUR MICRODRILL SYSTEMSK945104MICROMED PARTIAL REGULAR AND PARTIAL OFFSET

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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.

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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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