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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 K934552
Device Name PERIPUMP
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 Number884.1425
Classification Product Code
HIR  
Date Received09/21/1993
Decision Date 08/09/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
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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