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FDA 510(k) Application Details - K964690
Device Classification Name
Collector, Urine, (And Accessories) For Indwelling Catheter
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510(K) Number
K964690
Device Name
Collector, Urine, (And Accessories) For Indwelling Catheter
Applicant
CLEVELAND MEDICAL DEVICES, INC.
11000 CEDAR AVE., SUITE 130
CLEVELAND, OH 44106 US
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Contact
ROBERT N SCHMIDT
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Regulation Number
876.5250
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Classification Product Code
KNX
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More FDA Info for this Product Code
Date Received
11/22/1996
Decision Date
03/21/1997
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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