FDA 510(k) Application Details - K110257

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K110257
Device Name Laparoscope, General & Plastic Surgery
Applicant CAREFUSION 2200, INC.
1500 WAUKEGAN ROAD
MCGAW PARK, IL 60085 US
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Contact JANE WEBER
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 01/28/2011
Decision Date 05/06/2011
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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