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FDA 510(k) Application Details - K992653
Device Classification Name
Needle, Fistula
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510(K) Number
K992653
Device Name
Needle, Fistula
Applicant
DIASOL, INC.
13212 RAYMER ST.
NORTH HOLLYWOOD, CA 91605 US
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Contact
MONICA ABELES
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Regulation Number
876.5540
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Classification Product Code
FIE
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More FDA Info for this Product Code
Date Received
08/06/1999
Decision Date
10/27/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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