FDA 510(k) Application Details - K062240

Device Classification Name Accessories, Catheter, G-U

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510(K) Number K062240
Device Name Accessories, Catheter, G-U
Applicant CHIEF MEDICAL LLC
PO BOX 772
105 PIONEER LANE
TETON VILLAGE, WY 83025 US
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Contact SCOTT HORN
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Regulation Number 876.5130

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Classification Product Code KNY
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Date Received 08/02/2006
Decision Date 10/16/2006
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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