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FDA 510(k) Application Details - K161445
Device Classification Name
Catheter, Straight
More FDA Info for this Device
510(K) Number
K161445
Device Name
Catheter, Straight
Applicant
ADAPTA MEDICAL, INC
142 TALAMINE COURT
COLORADO SPRINGS, CO 80907 US
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Contact
Adrian Elfe
Other 510(k) Applications for this Contact
Regulation Number
876.5130
More FDA Info for this Regulation Number
Classification Product Code
EZD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/25/2016
Decision Date
08/16/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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