FDA 510(k) Application Details - K034029

Device Classification Name Clip, Vas Deferens

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510(K) Number K034029
Device Name Clip, Vas Deferens
Applicant GYRX, LLC
11222 ST. JOHNS INDUSTRIAL
PARKWAY N.
JACKSONVILLE, FL 32246 US
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Contact BRIAN S ZIMOVAN
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Regulation Number 878.4300

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Classification Product Code NJC
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Date Received 12/29/2003
Decision Date 03/05/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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