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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Perineometer
510(k) Number K994079
Device Name REFLEX TREATMENT SYSTEM
Applicant
Deschutes Medical Products, Inc.
1011 SW Emkay Dr., Suite 104
Bend,  OR  97702
Applicant Contact DENISE BESTWICK
Correspondent
Deschutes Medical Products, Inc.
1011 SW Emkay Dr., Suite 104
Bend,  OR  97702
Correspondent Contact DENISE BESTWICK
Regulation Number884.1425
Classification Product Code
HIR  
Date Received12/02/1999
Decision Date 03/01/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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