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FDA 510(k) Application Details - K033477
Device Classification Name
Catheter, Urological (Antimicrobial) And Accessories
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510(K) Number
K033477
Device Name
Catheter, Urological (Antimicrobial) And Accessories
Applicant
ROCHESTER MEDICAL CORP.
ONE ROCHESTER MEDICAL DR.
STEWARTVILLE, MN 55976 US
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Contact
ROB ANGLIN
Other 510(k) Applications for this Contact
Regulation Number
876.5130
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Classification Product Code
MJC
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Date Received
11/03/2003
Decision Date
06/10/2004
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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