FDA 510(k) Application Details - K050027

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K050027
Device Name Laparoscope, General & Plastic Surgery
Applicant GMP/COMPANIES, INC.
ONE EAST BROWARD BLVD.
SUITE 1701
FORT LAUDERDALE, FL 33301 US
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Contact RALPH JUGO
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 01/06/2005
Decision Date 01/27/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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