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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 K002329
Device Name PELVX GELLHORN VAGINAL PESSARY 603-608
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 Number884.3575
Classification Product Code
HHW  
Date Received08/01/2000
Decision Date 09/18/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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