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FDA 510(k)

ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS

K-Number: K093747 · 2010-05-07

ApplicantC.R. Bard, Inc.
Decision Date2010-05-07
Product CodeOTN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2010-05-07 under 510(k) number K093747. The device is classified under product code OTN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS?

ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS is a medical device that received FDA 510(k) clearance on 2010-05-07. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K093747.

When did ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS receive FDA 510(k) clearance?

ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS received FDA 510(k) clearance on 2010-05-07, under 510(k) number K093747.

Who is the listed applicant for ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS?

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

What is the FDA product code for ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS?

The FDA product code for ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS is OTN.

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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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