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FDA 510(k)

DEPUY HEMODRAIN

K-Number: K811557 · 1981-07-20

ApplicantDepuy, Inc.
Decision Date1981-07-20
Product CodeGCY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DEPUY HEMODRAIN is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1981-07-20 under 510(k) number K811557. The device is classified under product code GCY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEPUY HEMODRAIN?

DEPUY HEMODRAIN is a medical device that received FDA 510(k) clearance on 1981-07-20. The listed applicant is Depuy, Inc.. The 510(k) number is K811557.

When did DEPUY HEMODRAIN receive FDA 510(k) clearance?

DEPUY HEMODRAIN received FDA 510(k) clearance on 1981-07-20, under 510(k) number K811557.

Who is the listed applicant for DEPUY HEMODRAIN?

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

What is the FDA product code for DEPUY HEMODRAIN?

The FDA product code for DEPUY HEMODRAIN is GCY.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Depuy, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 303 devices →

Related Devices (Code: GCY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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