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FDA 510(k)

HASTINGS BIPOLAR ENDOPROSTHESIS

K-Number: K842344 · 1984-09-12

ApplicantJohnson & Johnson Professionals, Inc.
Decision Date1984-09-12
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HASTINGS BIPOLAR ENDOPROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Professionals, Inc.. It received FDA 510(k) clearance on 1984-09-12 under 510(k) number K842344. 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 HASTINGS BIPOLAR ENDOPROSTHESIS?

HASTINGS BIPOLAR ENDOPROSTHESIS is a medical device that received FDA 510(k) clearance on 1984-09-12. The listed applicant is Johnson & Johnson Professionals, Inc.. The 510(k) number is K842344.

When did HASTINGS BIPOLAR ENDOPROSTHESIS receive FDA 510(k) clearance?

HASTINGS BIPOLAR ENDOPROSTHESIS received FDA 510(k) clearance on 1984-09-12, under 510(k) number K842344.

Who is the listed applicant for HASTINGS BIPOLAR ENDOPROSTHESIS?

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

What is the FDA product code for HASTINGS BIPOLAR ENDOPROSTHESIS?

The FDA product code for HASTINGS BIPOLAR ENDOPROSTHESIS 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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