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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 K926218
Device Name EISMAN-TRIES MEP (MULTIPLE ELECTRODE PROBE)
Applicant
Sandhill Scientific, Inc.
1501-N W. Campus Dr.
Littleton,  CO  80120
Applicant Contact JACQUELINE Q THOMAS
Correspondent
Sandhill Scientific, Inc.
1501-N W. Campus Dr.
Littleton,  CO  80120
Correspondent Contact JACQUELINE Q THOMAS
Regulation Number884.1425
Classification Product Code
HIR  
Date Received12/10/1992
Decision Date 08/26/1994
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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