FDA 510(k) Application Details - K041159

Device Classification Name Staple, Implantable

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510(K) Number K041159
Device Name Staple, Implantable
Applicant JMS, INC.
1221 1ST STREET SOUTH
# 7A
JACKSONVILLE BEACH, FL 32250 US
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Contact JOHN I SHIPP
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Regulation Number 878.4750

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Classification Product Code GDW
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Date Received 05/03/2004
Decision Date 07/27/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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