FDA 510(k) Application Details - K031828

Device Classification Name Forceps, General & Plastic Surgery

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510(K) Number K031828
Device Name Forceps, General & Plastic Surgery
Applicant FOCUS MEDICAL, LLC.
23 FRANCIS J. CLARKE CIRCLE
BETHEL, CT 06801 US
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Contact JOHN LEE, JR
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Regulation Number 878.4800

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Classification Product Code GEN
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Date Received 06/13/2003
Decision Date 07/17/2003
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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