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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 K072808
Device Name SPEEDICATH COMPACT
Applicant
COLOPLAST CORP.
1601 WEST RIVER N
MINNEAPOLIS,  MN  55411
Applicant Contact REBEKA STOLTMAN
Correspondent
COLOPLAST CORP.
1601 WEST RIVER N
MINNEAPOLIS,  MN  55411
Correspondent Contact REBEKA STOLTMAN
Regulation Number876.5130
Classification Product Code
GBM  
Date Received10/01/2007
Decision Date 11/09/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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