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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Penile
510(k) Number K181673
Device Name Rigi10 Malleable Penile Prosthesis
Applicant
Rigicon Inc.
150 Motor Pkwy S401
Hauppauge,  NY  11788
Applicant Contact Ahmet Melih Luleci
Correspondent
Rigicon Inc.
150 Motor Pkwy S401
Hauppauge,  NY  11788
Correspondent Contact Ahmet Melih Luleci
Regulation Number876.3630
Classification Product Code
FAE  
Date Received06/25/2018
Decision Date 04/15/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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