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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 K002617
Device Name PERIFORM PERINEOMETRIC PROBE, MODEL 8300
Applicant
Neen Design , Ltd.
Old Pharmacy Yard, Church St.
Dereham, Norfolk,  GB NR19 1DJ
Applicant Contact MARK READ
Correspondent
Neen Design , Ltd.
Old Pharmacy Yard, Church St.
Dereham, Norfolk,  GB NR19 1DJ
Correspondent Contact MARK READ
Regulation Number884.1425
Classification Product Code
HIR  
Date Received08/23/2000
Decision Date 04/05/2001
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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