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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 K974036
Device Name PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE
Applicant
The Prometheus Group
2 Mallards Cove
Duxbury,  MA  02332
Applicant Contact RICHARD HORTON
Correspondent
The Prometheus Group
2 Mallards Cove
Duxbury,  MA  02332
Correspondent Contact RICHARD HORTON
Regulation Number884.1425
Classification Product Code
HIR  
Date Received10/24/1997
Decision Date 12/22/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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