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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Irrigation Solution
510(k) Number K965136
Device Name UROSURGE UROTHERM FLUID WARMING SYSTEM
Applicant
Princeton Regulatory Assoc.
116 Village Blvd., Suite 200
Princeton,  NJ  08540
Applicant Contact THOMAS BECZE
Correspondent
Princeton Regulatory Assoc.
116 Village Blvd., Suite 200
Princeton,  NJ  08540
Correspondent Contact THOMAS BECZE
Regulation Number890.5950
Classification Product Code
LHC  
Date Received12/23/1996
Decision Date 10/16/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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