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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 K981277
Device Name PERIFORM
Applicant
Verimed Holdings, Inc.
11950 NW 39th St., Suite D
Coral Springs,  FL  33065
Applicant Contact KISHORE PUPPALA
Correspondent
Verimed Holdings, Inc.
11950 NW 39th St., Suite D
Coral Springs,  FL  33065
Correspondent Contact KISHORE PUPPALA
Regulation Number884.1425
Classification Product Code
HIR  
Date Received04/08/1998
Decision Date 11/20/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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