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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Collector, Urine, (And Accessories) For Indwelling Catheter
510(k) Number K800694
Device Name MMG DISPOSABLE URINARY LEG BAG
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 Number876.5250
Classification Product Code
KNX  
Date Received03/27/1980
Decision Date 05/30/1980
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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