FDA 510(k) Application Details - K070073

Device Classification Name

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510(K) Number K070073
Device Name ALIGN URETHRAL SUPPORT SYSTEM
Applicant C.R. BARD, INC.
13183 HARLAND DRIVE
COVINGTON, GA 30014-6421 US
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Contact JULIE J BASSETT
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Regulation Number

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Classification Product Code OTN
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Date Received 01/08/2007
Decision Date 03/21/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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