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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 K901441
Device Name ALBERT MORTON UROLOGICAL CATHETER
Applicant
Transinternational Marketing Group
207 E. Bay St.
Suite 302 A
Port Of Charleston,  SC  29401
Applicant Contact RICHARD FOWLER
Correspondent
Transinternational Marketing Group
207 E. Bay St.
Suite 302 A
Port Of Charleston,  SC  29401
Correspondent Contact RICHARD FOWLER
Regulation Number876.5130
Classification Product Code
GBM  
Date Received03/27/1990
Decision Date 06/22/1990
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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