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FDA 510(k) Applications Submitted by James Elist
FDA 510(k) Number
Submission Date
Device Name
Applicant
K220760
03/15/2022
Pre-Formed Penile Silicone Block
International Medical Devices, Inc.
K181387
05/25/2018
Pre-Formed Penile Silicone Block
International Medical Devices, Inc.
K042380
09/01/2004
SILICONE BLOCK
NATIONAL MEDICAL DEVICES, INC.
K162624
09/20/2016
Pre-Formed Penile Silicone Block
INTERNATIONAL MEDICAL DEVICES, INC.
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