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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Irrigation, Urological
510(k) Number K951569
Device Name SURGACTIVATOR
Applicant
Deschutes Medical Products, Inc.
P.O. Box 627
Bend,  OR  97709
Applicant Contact MATTHEW W HOSKINS
Correspondent
Deschutes Medical Products, Inc.
P.O. Box 627
Bend,  OR  97709
Correspondent Contact MATTHEW W HOSKINS
Regulation Number876.5130
Classification Product Code
LJH  
Subsequent Product Code
FFY  
Date Received04/04/1995
Decision Date 06/06/1995
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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