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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 K913912
Device Name VERIMED PERINEOMETER
Applicant
Verimed Holdings, Inc.
1401 E. Broward Blvd.
Suite 200
Fort Lauderdale,  FL  33301
Applicant Contact DOUGLAS MEE
Correspondent
Verimed Holdings, Inc.
1401 E. Broward Blvd.
Suite 200
Fort Lauderdale,  FL  33301
Correspondent Contact DOUGLAS MEE
Regulation Number884.1425
Classification Product Code
HIR  
Date Received08/29/1991
Decision Date 06/16/1992
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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