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FDA 510(k)

CONCEPT MICROMILL

K-Number: K912957 · 1991-10-04

ApplicantConcept, Inc.
Decision Date1991-10-04
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CONCEPT MICROMILL is the device name listed in this FDA 510(k) record. The listed applicant is Concept, Inc.. It received FDA 510(k) clearance on 1991-10-04 under 510(k) number K912957. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONCEPT MICROMILL?

CONCEPT MICROMILL is a medical device that received FDA 510(k) clearance on 1991-10-04. The listed applicant is Concept, Inc.. The 510(k) number is K912957.

When did CONCEPT MICROMILL receive FDA 510(k) clearance?

CONCEPT MICROMILL received FDA 510(k) clearance on 1991-10-04, under 510(k) number K912957.

Who is the listed applicant for CONCEPT MICROMILL?

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 MICROMILL?

The FDA product code for CONCEPT MICROMILL is HRX.

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Other records listing Concept, Inc. as applicant

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K912640CONCEPT ENDOSTEAL FIXATION DEVICEK896648CONCEPT UNICOMPARTMENTAL KNEE SYSTEMK894929STAPLE FIXATION SYSTEMK892376INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.)K891109PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBEK881954CONCEPT POWER SYSTEM

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Related Devices (Code: HRX)

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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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