FDA 510(k) Application Details - K150781

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K150781
Device Name Laparoscope, General & Plastic Surgery
Applicant BOEHRINGER LABORATORIES, LLC
300 Thoms Drive
Phoenixville, PA 19460 US
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Contact Chris Radl
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 03/25/2015
Decision Date 06/19/2015
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

FDA Source Information for K150781


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