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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Elastomer, Silicone Block
510(k) Number K200073
Device Name AugMENTA Penile Implant
Applicant
Augmenta, LLC
1315 St. Joesph Pkwy., Suite 1700
Houston,  TX  77002
Applicant Contact Robert J Cornell
Correspondent
DuVal & Associates, P.A.
825 Nicollet Mall, Suite 1820
Medical Arts Bldg.
Minneapolois,  MN  55402
Correspondent Contact Lisa L. Pritchard
Regulation Number874.3620
Classification Product Code
MIB  
Date Received01/14/2020
Decision Date 09/30/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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