FDA 510(k) Application Details - K000060

Device Classification Name Staple, Implantable

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510(K) Number K000060
Device Name Staple, Implantable
Applicant SENORX, INC.
13766 ALTON PKWY.
SUITE 144
IRVINE, CA 92677 US
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Contact AMY BOUCLY
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Regulation Number 878.4750

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Classification Product Code GDW
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Date Received 01/10/2000
Decision Date 03/27/2000
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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