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FDA 510(k)

HAPEX MALLEABLE PORP

K-Number: K950885 · 1995-03-15

ApplicantSmith & Nephew Richards, Inc.
Decision Date1995-03-15
Product CodeETB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HAPEX MALLEABLE PORP is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Richards, Inc.. It received FDA 510(k) clearance on 1995-03-15 under 510(k) number K950885. The device is classified under product code ETB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HAPEX MALLEABLE PORP?

HAPEX MALLEABLE PORP is a medical device that received FDA 510(k) clearance on 1995-03-15. The listed applicant is Smith & Nephew Richards, Inc.. The 510(k) number is K950885.

When did HAPEX MALLEABLE PORP receive FDA 510(k) clearance?

HAPEX MALLEABLE PORP received FDA 510(k) clearance on 1995-03-15, under 510(k) number K950885.

Who is the listed applicant for HAPEX MALLEABLE PORP?

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

What is the FDA product code for HAPEX MALLEABLE PORP?

The FDA product code for HAPEX MALLEABLE PORP is ETB.

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Other records listing Smith & Nephew Richards, Inc. as applicant

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Related Devices (Code: ETB)

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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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