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FDA 510(k)

BDH BIPOLAR FEMORAL COMPONENT A3

K-Number: K833404 · 1984-03-02

ApplicantCarbomedics, Inc.
Decision Date1984-03-02
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BDH BIPOLAR FEMORAL COMPONENT A3 is the device name listed in this FDA 510(k) record. The listed applicant is Carbomedics, Inc.. It received FDA 510(k) clearance on 1984-03-02 under 510(k) number K833404. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BDH BIPOLAR FEMORAL COMPONENT A3?

BDH BIPOLAR FEMORAL COMPONENT A3 is a medical device that received FDA 510(k) clearance on 1984-03-02. The listed applicant is Carbomedics, Inc.. The 510(k) number is K833404.

When did BDH BIPOLAR FEMORAL COMPONENT A3 receive FDA 510(k) clearance?

BDH BIPOLAR FEMORAL COMPONENT A3 received FDA 510(k) clearance on 1984-03-02, under 510(k) number K833404.

Who is the listed applicant for BDH BIPOLAR FEMORAL COMPONENT A3?

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

What is the FDA product code for BDH BIPOLAR FEMORAL COMPONENT A3?

The FDA product code for BDH BIPOLAR FEMORAL COMPONENT A3 is KWY.

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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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