FDA 510(k) Application Details - K180134

Device Classification Name Forceps, Biopsy, Electric

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510(K) Number K180134
Device Name Forceps, Biopsy, Electric
Applicant Slater Endoscopy, LLC
14000 NW 58 Court
Miami Lakes, FL 33014 US
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Contact John Starkey
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Regulation Number 876.4300

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Classification Product Code KGE
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Date Received 01/17/2018
Decision Date 06/29/2018
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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