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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dilator, urethral, mechanical
510(k) Number K933957
Device Name DILATING URETHRAL SOUND
Applicant
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
P.O. BOX 227
SPENCER,  IN  47460
Applicant Contact TAMMY BACON
Correspondent
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
P.O. BOX 227
SPENCER,  IN  47460
Correspondent Contact TAMMY BACON
Regulation Number876.5520
Classification Product Code
FAH  
Date Received08/12/1993
Decision Date 11/17/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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