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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pessary, Vaginal
510(k) Number K974117
Device Name PELVX DONUT, PELVX CUBE
Applicant
Deschutes Medical Products, Inc.
1011 SW Emkay Dr., Suite 104
Bend,  OR  97702
Applicant Contact MATTHEW W HOSKINS
Correspondent
Deschutes Medical Products, Inc.
1011 SW Emkay Dr., Suite 104
Bend,  OR  97702
Correspondent Contact MATTHEW W HOSKINS
Regulation Number884.3575
Classification Product Code
HHW  
Date Received10/31/1997
Decision Date 04/27/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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