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FDA 510(k)

P.F.C.(R) BIPOLAR HIP SYSTEM - 22MM BIPOLAR

K-Number: K945793 · 1995-04-10

ApplicantJohnson & Johnson Professionals, Inc.
Decision Date1995-04-10
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

P.F.C.(R) BIPOLAR HIP SYSTEM - 22MM BIPOLAR 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 1995-04-10 under 510(k) number K945793. 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 P.F.C.(R) BIPOLAR HIP SYSTEM - 22MM BIPOLAR?

P.F.C.(R) BIPOLAR HIP SYSTEM - 22MM BIPOLAR is a medical device that received FDA 510(k) clearance on 1995-04-10. The listed applicant is Johnson & Johnson Professionals, Inc.. The 510(k) number is K945793.

When did P.F.C.(R) BIPOLAR HIP SYSTEM - 22MM BIPOLAR receive FDA 510(k) clearance?

P.F.C.(R) BIPOLAR HIP SYSTEM - 22MM BIPOLAR received FDA 510(k) clearance on 1995-04-10, under 510(k) number K945793.

Who is the listed applicant for P.F.C.(R) BIPOLAR HIP SYSTEM - 22MM BIPOLAR?

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 P.F.C.(R) BIPOLAR HIP SYSTEM - 22MM BIPOLAR?

The FDA product code for P.F.C.(R) BIPOLAR HIP SYSTEM - 22MM BIPOLAR 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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