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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Cystometric, Non-Electric And Accessories
510(k) Number K955019
Device Name UROTRACT I
Applicant
Dornier Medtech America, Inc.
1155 Roberts Blvd.
Kennesaw,  GA  30144
Applicant Contact DEBORAH MOORE
Correspondent
Dornier Medtech America, Inc.
1155 Roberts Blvd.
Kennesaw,  GA  30144
Correspondent Contact DEBORAH MOORE
Regulation Number876.4890
Classification Product Code
KQS  
Date Received11/02/1995
Decision Date 12/06/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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