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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 K993651
Device Name O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER
Applicant
Sc Hennig Enterprises Europe Srl
25 Shann St.
Floreat Park
Western Australia,  AU 6014
Applicant Contact GEORGE O'NEIL
Correspondent
Sc Hennig Enterprises Europe Srl
25 Shann St.
Floreat Park
Western Australia,  AU 6014
Correspondent Contact GEORGE O'NEIL
Regulation Number876.5130
Classification Product Code
GBM  
Date Received10/29/1999
Decision Date 12/23/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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