Decision Date2007-03-21
Product CodeOTN
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
ALIGN URETHRAL SUPPORT SYSTEM 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 2007-03-21 under 510(k) number K070073. 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 URETHRAL SUPPORT SYSTEM?
ALIGN URETHRAL SUPPORT SYSTEM is a medical device that received FDA 510(k) clearance on 2007-03-21. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K070073.
When did ALIGN URETHRAL SUPPORT SYSTEM receive FDA 510(k) clearance?
ALIGN URETHRAL SUPPORT SYSTEM received FDA 510(k) clearance on 2007-03-21, under 510(k) number K070073.
Who is the listed applicant for ALIGN URETHRAL SUPPORT SYSTEM?
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 URETHRAL SUPPORT SYSTEM?
The FDA product code for ALIGN URETHRAL SUPPORT SYSTEM is OTN.
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Official Source
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