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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
510(k) Number K910022
Device Name MMG/O'NEIL URINARY CATHETERIZATION SYSTEM KIT
Applicant
Medical Marketing Group
5335 Dividend Dr.
Decatur,  GA  30035
Applicant Contact TIMOTHY D GOLDEN
Correspondent
Medical Marketing Group
5335 Dividend Dr.
Decatur,  GA  30035
Correspondent Contact TIMOTHY D GOLDEN
Regulation Number876.5130
Classification Product Code
FCM  
Date Received01/03/1991
Decision Date 04/02/1991
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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