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FDA 510(k)

MONOTUBE CARBON TUBE

K-Number: K963614 · 1996-11-06

ApplicantHowmedica Corp.
Decision Date1996-11-06
Product CodeJEC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MONOTUBE CARBON TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1996-11-06 under 510(k) number K963614. The device is classified under product code JEC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONOTUBE CARBON TUBE?

MONOTUBE CARBON TUBE is a medical device that received FDA 510(k) clearance on 1996-11-06. The listed applicant is Howmedica Corp.. The 510(k) number is K963614.

When did MONOTUBE CARBON TUBE receive FDA 510(k) clearance?

MONOTUBE CARBON TUBE received FDA 510(k) clearance on 1996-11-06, under 510(k) number K963614.

Who is the listed applicant for MONOTUBE CARBON TUBE?

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

What is the FDA product code for MONOTUBE CARBON TUBE?

The FDA product code for MONOTUBE CARBON TUBE is JEC.

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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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