FDA 510(k) Application Details - K043284

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K043284
Device Name Laparoscope, General & Plastic Surgery
Applicant ARMSTRONG HEALTHCARE LIMITED
KNAVES BEECH BUSINESS CENTRE
LOUDWATER
HIGH WYCOMBE HP10 9QR GB
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Contact PATRICK A FINLAY
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 11/26/2004
Decision Date 02/25/2005
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 N
Expedited Review



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