FDA 510(k) Application Details - K063429

Device Classification Name Clamp, Circumcision

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510(K) Number K063429
Device Name Clamp, Circumcision
Applicant GENERIC MEDICAL DEVICE, INC.
3906 ROSELAND ST.
HOUSTON, TX 77006 US
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Contact MONICA MONTANEZ
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Regulation Number 884.4530

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Classification Product Code HFX
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Date Received 11/13/2006
Decision Date 01/17/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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