FDA 510(k) Application Details - K111013

Device Classification Name Cord, Electric, For Endoscope

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510(K) Number K111013
Device Name Cord, Electric, For Endoscope
Applicant SANDHILL SCIENTIFIC, INC.
4655 KIRKWOOD CT
BOULDER, CO 80301 US
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Contact LEWIS WARD
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Regulation Number 876.1500

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Classification Product Code FFZ
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Date Received 04/11/2011
Decision Date 12/19/2011
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

FDA Source Information for K111013


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