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FDA 510(k)

SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079

K-Number: K051848 · 2005-08-11

ApplicantDavol Inc., Sub. C. R. Bard, Inc.
Decision Date2005-08-11
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079 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 2005-08-11 under 510(k) number K051848. 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 II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079?

SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079 is a medical device that received FDA 510(k) clearance on 2005-08-11. The listed applicant is Davol Inc., Sub. C. R. Bard, Inc.. The 510(k) number is K051848.

When did SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079 receive FDA 510(k) clearance?

SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079 received FDA 510(k) clearance on 2005-08-11, under 510(k) number K051848.

Who is the listed applicant for SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079?

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 II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079?

The FDA product code for SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079 is GDW.

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Official Source

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