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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Suprapubic (And Accessories)
510(k) Number K952187
Device Name RUSCH SUPRAFLEX SUPRAPUBIC CYSTOSTOMY CATHETER KIT, STERILE
Applicant
Rusch, Inc.
Tall Pines Park
Jeffrey,  NH  03452
Applicant Contact NEIL R ARMSTRONG
Correspondent
Rusch, Inc.
Tall Pines Park
Jeffrey,  NH  03452
Correspondent Contact NEIL R ARMSTRONG
Regulation Number876.5090
Classification Product Code
KOB  
Date Received05/09/1995
Decision Date 07/25/1995
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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