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FDA 510(k)

DEPUY OPTI-CON AND E-Z SHIELD SYSTEMS

K-Number: K964114 · 1997-05-06

ApplicantDepuy, Inc.
Decision Date1997-05-06
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DEPUY OPTI-CON AND E-Z SHIELD SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1997-05-06 under 510(k) number K964114. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEPUY OPTI-CON AND E-Z SHIELD SYSTEMS?

DEPUY OPTI-CON AND E-Z SHIELD SYSTEMS is a medical device that received FDA 510(k) clearance on 1997-05-06. The listed applicant is Depuy, Inc.. The 510(k) number is K964114.

When did DEPUY OPTI-CON AND E-Z SHIELD SYSTEMS receive FDA 510(k) clearance?

DEPUY OPTI-CON AND E-Z SHIELD SYSTEMS received FDA 510(k) clearance on 1997-05-06, under 510(k) number K964114.

Who is the listed applicant for DEPUY OPTI-CON AND E-Z SHIELD SYSTEMS?

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 OPTI-CON AND E-Z SHIELD SYSTEMS?

The FDA product code for DEPUY OPTI-CON AND E-Z SHIELD SYSTEMS is FXX.

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Other records listing Depuy, Inc. as applicant

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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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