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FDA 510(k)

SMARTMIX PRE-FILLED MIXING SYSTEM

K-Number: K042591 · 2004-10-22

ApplicantDePuy Orthopaedics, Inc.
Decision Date2004-10-22
Product CodeKIH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SMARTMIX PRE-FILLED MIXING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2004-10-22 under 510(k) number K042591. The device is classified under product code KIH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMARTMIX PRE-FILLED MIXING SYSTEM?

SMARTMIX PRE-FILLED MIXING SYSTEM is a medical device that received FDA 510(k) clearance on 2004-10-22. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K042591.

When did SMARTMIX PRE-FILLED MIXING SYSTEM receive FDA 510(k) clearance?

SMARTMIX PRE-FILLED MIXING SYSTEM received FDA 510(k) clearance on 2004-10-22, under 510(k) number K042591.

Who is the listed applicant for SMARTMIX PRE-FILLED MIXING SYSTEM?

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

What is the FDA product code for SMARTMIX PRE-FILLED MIXING SYSTEM?

The FDA product code for SMARTMIX PRE-FILLED MIXING SYSTEM is KIH.

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Related Devices (Code: KIH)

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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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