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FDA 510(k)

LIGHT HANDLE COVER

K-Number: K832278 · 1983-09-29

ApplicantConcept, Inc.
Decision Date1983-09-29
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LIGHT HANDLE COVER is the device name listed in this FDA 510(k) record. The listed applicant is Concept, Inc.. It received FDA 510(k) clearance on 1983-09-29 under 510(k) number K832278. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIGHT HANDLE COVER?

LIGHT HANDLE COVER is a medical device that received FDA 510(k) clearance on 1983-09-29. The listed applicant is Concept, Inc.. The 510(k) number is K832278.

When did LIGHT HANDLE COVER receive FDA 510(k) clearance?

LIGHT HANDLE COVER received FDA 510(k) clearance on 1983-09-29, under 510(k) number K832278.

Who is the listed applicant for LIGHT HANDLE COVER?

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 LIGHT HANDLE COVER?

The FDA product code for LIGHT HANDLE COVER is KKX.

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Other records listing Concept, Inc. as applicant

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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: KKX)

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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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