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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 K861683
Device Name MONSANTO SANTOPRENE (PERITONE DEVICE)
Applicant
Peritone Research, Ltd.
75-04 249 St.
Bellerose,  NY  11426
Applicant Contact KAISER, PH.D.
Correspondent
Peritone Research, Ltd.
75-04 249 St.
Bellerose,  NY  11426
Correspondent Contact KAISER, PH.D.
Regulation Number884.1425
Classification Product Code
HIR  
Date Received05/01/1986
Decision Date 06/02/1986
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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