FDA 510(k) Application Details - K060494

Device Classification Name Staple, Implantable

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510(K) Number K060494
Device Name Staple, Implantable
Applicant MEDCHANNEL, LLC
55 WORCESTER STREET, #3
BOSTON, MA 02118 US
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Contact FREDERICK TOBIA
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Regulation Number 878.4750

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Classification Product Code GDW
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Date Received 02/24/2006
Decision Date 07/03/2006
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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