FDA 510(k) Application Details - K112456

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K112456
Device Name Laparoscope, General & Plastic Surgery
Applicant Teleflex Medical, Inc.
2917 WECK DR.
RESEARCH TRIANGLE PARK, NC 27709 US
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Contact NATALIE SMITH
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 08/25/2011
Decision Date 10/04/2011
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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