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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, urethral
510(K) Number K121457
Model 28522
Device Name SPEEDICATH COMPACT SET (12 FR)
Applicant
COLOPLAST CORP.
1601 west river rd north
minneapolis,  MN  55411
Contact brian schmidt
Regulation Number876.5130
Classification Product Code
GBM  
Date Received05/16/2012
Decision Date 10/02/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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