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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 K162624
Device Name Pre-Formed Penile Silicone Block
Applicant
INTERNATIONAL MEDICAL DEVICES, INC.
717 NORTH MAPLE DRIVE
BEVERLY HILLS,  CA  90210
Applicant Contact JAMES ELIST
Correspondent
ACKNOWLEDGE REGULATORY STRATEGIES
2834 HAWTHORN ST.
SAN DIEGO,  CA  92104
Correspondent Contact ALLISON KOMIYAMA
Regulation Number874.3620
Classification Product Code
MIB  
Date Received09/20/2016
Decision Date 02/01/2017
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
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