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FDA 510(k) Application Details - K131803
Device Classification Name
Accessories, Catheter, G-U
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510(K) Number
K131803
Device Name
Accessories, Catheter, G-U
Applicant
SOLACE THERAPEUTICS
135 NEWBURY ST
FRAMINGHAM, MA 01701 US
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Contact
WILLIAM GRUBER
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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
06/19/2013
Decision Date
08/20/2013
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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