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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Radiographic, Tilting
510(k) Number K903395
Device Name UROMAT 2000
Applicant
Pausch Corp.
96 Birch Ave.
Little Silver,  NJ  07739
Applicant Contact TICE
Correspondent
Pausch Corp.
96 Birch Ave.
Little Silver,  NJ  07739
Correspondent Contact TICE
Regulation Number892.1980
Classification Product Code
IXR  
Date Received07/27/1990
Decision Date 08/30/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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