FDA 510(k) Application Details - K073039

Device Classification Name

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510(K) Number K073039
Device Name SPERMCHECK VASECTOMY
Applicant PRINCETON BIOMEDITECH CORP.
4242 U.S. RT. 1
MONMOUTH JUNCTION, NJ 08852-1905 US
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Contact KYUNG-AH KIM
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Regulation Number

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Classification Product Code POV
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Date Received 10/29/2007
Decision Date 01/24/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee HE - Hematology
Review Advisory Committee HE - Hematology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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