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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 K854821
Device Name MMG EXTERNAL FEMALE CATHETERS
Applicant
Medical Technologies of Georgia
P.O. Box 291
417 Glendale Rd.
Wilbraham,  MA  01095
Applicant Contact TIMOTHY D GOLDEN
Correspondent
Medical Technologies of Georgia
P.O. Box 291
417 Glendale Rd.
Wilbraham,  MA  01095
Correspondent Contact TIMOTHY D GOLDEN
Regulation Number876.5250
Classification Product Code
KNX  
Date Received12/03/1985
Decision Date 04/24/1986
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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