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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Paper, Obstetric Ph
510(k) Number K850858
Device Name OB-PH - PH TEST PAPER
Applicant
Uro Pharmaceuticals, Inc.
P.O. Box 2073
Port Angeles,  WA  98362
Applicant Contact NICHOLAS D ROTELLO
Correspondent
Uro Pharmaceuticals, Inc.
P.O. Box 2073
Port Angeles,  WA  98362
Correspondent Contact NICHOLAS D ROTELLO
Regulation Number862.1550
Classification Product Code
LNW  
Date Received03/01/1985
Decision Date 05/24/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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