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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
510(k) Number K933126
Device Name COMFORTCARE SYSTEM
Applicant
Patsy J. Trisler, J.D.
1700 Rockville Pike
Suite 535
Rockville,  MD  20852
Applicant Contact PATSY J TRISLER
Correspondent
Patsy J. Trisler, J.D.
1700 Rockville Pike
Suite 535
Rockville,  MD  20852
Correspondent Contact PATSY J TRISLER
Regulation Number876.5250
Classification Product Code
EYZ  
Subsequent Product Code
EYQ  
Date Received06/28/1993
Decision Date 02/25/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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