FDA 510(k) Application Details - K150939

Device Classification Name Endoscopic Grasping/Cutting Instrument, Non-Powered

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510(K) Number K150939
Device Name Endoscopic Grasping/Cutting Instrument, Non-Powered
Applicant SLATER ENDOSCOPY, LLC
14000 NW 58TH COURT
MIAMI LAKES, FL 33014 US
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Contact JOHN STARKEY
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Regulation Number 876.1500

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Classification Product Code OCZ
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Date Received 04/07/2015
Decision Date 06/08/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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