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FDA 510(k)

BDH UNIPOLAR FEMORAL COMPONENT A2

K-Number: K833403 · 1984-01-10

ApplicantCarbomedics, Inc.
Decision Date1984-01-10
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BDH UNIPOLAR FEMORAL COMPONENT A2 is the device name listed in this FDA 510(k) record. The listed applicant is Carbomedics, Inc.. It received FDA 510(k) clearance on 1984-01-10 under 510(k) number K833403. The device is classified under product code KWL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BDH UNIPOLAR FEMORAL COMPONENT A2?

BDH UNIPOLAR FEMORAL COMPONENT A2 is a medical device that received FDA 510(k) clearance on 1984-01-10. The listed applicant is Carbomedics, Inc.. The 510(k) number is K833403.

When did BDH UNIPOLAR FEMORAL COMPONENT A2 receive FDA 510(k) clearance?

BDH UNIPOLAR FEMORAL COMPONENT A2 received FDA 510(k) clearance on 1984-01-10, under 510(k) number K833403.

Who is the listed applicant for BDH UNIPOLAR FEMORAL COMPONENT A2?

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 UNIPOLAR FEMORAL COMPONENT A2?

The FDA product code for BDH UNIPOLAR FEMORAL COMPONENT A2 is KWL.

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Related Devices (Code: KWL)

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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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