FDA 510(k)

SALUTE FIXATION SYSTEM

K-Number: K050610 · 2005-05-25

ApplicantDavol Inc., Sub. C. R. Bard, Inc.

Decision Date2005-05-25

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

SALUTE FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Davol Inc., Sub. C. R. Bard, Inc.. It received FDA 510(k) clearance on 2005-05-25 under 510(k) number K050610. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SALUTE FIXATION SYSTEM?

SALUTE FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2005-05-25. The listed applicant is Davol Inc., Sub. C. R. Bard, Inc.. The 510(k) number is K050610.

When did SALUTE FIXATION SYSTEM receive FDA 510(k) clearance?

SALUTE FIXATION SYSTEM received FDA 510(k) clearance on 2005-05-25, under 510(k) number K050610.

Who is the listed applicant for SALUTE FIXATION SYSTEM?

The FDA 510(k) record lists Davol Inc., Sub. C. R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SALUTE FIXATION SYSTEM?

The FDA product code for SALUTE FIXATION SYSTEM is GDW.

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Other records listing Davol Inc., Sub. C. R. Bard, 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.