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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 K220760
Device Name Pre-Formed Penile Silicone Block
International Medical Devices, Inc.
717 North Maple Drive
Beverly Hills,  CA  90210
Applicant Contact James Elist
2251 San Diego Avenue
Suite B-257
San Diego,  CA  92110
Correspondent Contact Allison Komiyama
Regulation Number874.3620
Classification Product Code
Date Received03/15/2022
Decision Date 05/13/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT02477189
Reviewed by Third Party No
Combination Product No