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FDA 510(k)

GAS PLASMA STERILIZATION

K-Number: K944538 · 1995-09-26

ApplicantDepuy, Inc.
Decision Date1995-09-26
Product CodeHRY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GAS PLASMA STERILIZATION is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1995-09-26 under 510(k) number K944538. The device is classified under product code HRY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAS PLASMA STERILIZATION?

GAS PLASMA STERILIZATION is a medical device that received FDA 510(k) clearance on 1995-09-26. The listed applicant is Depuy, Inc.. The 510(k) number is K944538.

When did GAS PLASMA STERILIZATION receive FDA 510(k) clearance?

GAS PLASMA STERILIZATION received FDA 510(k) clearance on 1995-09-26, under 510(k) number K944538.

Who is the listed applicant for GAS PLASMA STERILIZATION?

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 GAS PLASMA STERILIZATION?

The FDA product code for GAS PLASMA STERILIZATION is HRY.

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Other records listing Depuy, Inc. as applicant

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Related Devices (Code: HRY)

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.

K193549SIGMA High Performance (HP) Partial Knee SystemDepuy Ireland UCK190633NanoOrtho NanoKnee® SystemNanoortho, LLCK152631MPO Total Knee Systems MR LabelingMicroport Orthopedics, Inc.K131167UNIVATIONAesculap Implant Systems, LLCK122277OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEMBiomet Manufacturing CorpK110415SIGNATURE PLANNER / SIGNATURE GUIDESMaterialise NV

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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