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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 K082436
Device Name EXTT-101
Applicant
APIMEDS, INC
5401 S. COTTONWOOD CT
GREENWOOD VILLAGE,  CO  80121
Applicant Contact Kevin Walls
Correspondent
APIMEDS, INC
5401 S. COTTONWOOD CT
GREENWOOD VILLAGE,  CO  80121
Correspondent Contact Kevin Walls
Regulation Number884.1425
Classification Product Code
HIR  
Date Received08/25/2008
Decision Date 05/29/2009
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
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