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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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More FDA Info for this Product Code
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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