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FDA 510(k) Application Details - K971764
Device Classification Name
Collector, Urine, (And Accessories) For Indwelling Catheter
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510(K) Number
K971764
Device Name
Collector, Urine, (And Accessories) For Indwelling Catheter
Applicant
WELCON, INC.
99 HARTFORD AVE.
PROVIDENCE, RI 02909 US
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Contact
GEORGE HIRD
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Regulation Number
876.5250
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Classification Product Code
KNX
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Date Received
05/13/1997
Decision Date
07/29/1997
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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