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FDA 510(k)

CONCEPT DEFRERE ELECTRODE

K-Number: K851040 · 1985-07-11

ApplicantConcept, Inc.
Decision Date1985-07-11
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CONCEPT DEFRERE ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Concept, Inc.. It received FDA 510(k) clearance on 1985-07-11 under 510(k) number K851040. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONCEPT DEFRERE ELECTRODE?

CONCEPT DEFRERE ELECTRODE is a medical device that received FDA 510(k) clearance on 1985-07-11. The listed applicant is Concept, Inc.. The 510(k) number is K851040.

When did CONCEPT DEFRERE ELECTRODE receive FDA 510(k) clearance?

CONCEPT DEFRERE ELECTRODE received FDA 510(k) clearance on 1985-07-11, under 510(k) number K851040.

Who is the listed applicant for CONCEPT DEFRERE ELECTRODE?

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

What is the FDA product code for CONCEPT DEFRERE ELECTRODE?

The FDA product code for CONCEPT DEFRERE ELECTRODE is GEI.

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Other records listing Concept, Inc. 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.

K912640CONCEPT ENDOSTEAL FIXATION DEVICEK912957CONCEPT MICROMILLK896648CONCEPT UNICOMPARTMENTAL KNEE SYSTEMK894929STAPLE FIXATION SYSTEMK892376INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.)K891109PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE

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Related Devices (Code: GEI)

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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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