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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 K860552
Device Name PERITONE DISPOSAL SHEATH - RUBBER AND VINYL
Applicant
LAURIE ANN KAISER, PH.D.
75-04 - 249TH ST.
BELLEROSE,  NY  11426
Applicant Contact ANN KAISER
Correspondent
LAURIE ANN KAISER, PH.D.
75-04 - 249TH ST.
BELLEROSE,  NY  11426
Correspondent Contact ANN KAISER
Regulation Number884.1425
Classification Product Code
HIR  
Date Received02/14/1986
Decision Date 04/17/1986
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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