FDA 510(k) Application Details - K081169

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K081169
Device Name Laparoscope, General & Plastic Surgery
Applicant COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
60 MIDDLETOWN AVENUE
NORTH HAVEN, CT 06473 US
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Contact TIM LOHNES
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 04/24/2008
Decision Date 05/23/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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