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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 K133990
Device Name IEVA REHABILITATIVE POSITIONAL DEVICE
Applicant
REMENDIUM LABS, LLC
340 EAST PARKER ROAD
baton rouge,  LA  70803
Applicant Contact yolanda lorie
Correspondent
REMENDIUM LABS, LLC
340 EAST PARKER ROAD
baton rouge,  LA  70803
Correspondent Contact yolanda lorie
Regulation Number884.1425
Classification Product Code
HIR  
Date Received12/27/2013
Decision Date 10/09/2014
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
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