K-number	K162624
Device name	Pre-Formed Penile Silicone Block
Applicant	International Medical Devices, Inc.
Product code	MIB
Device class	Class II
Decision date	Feb 1, 2017
Decision	Substantially Equivalent
Regulation	874.3620

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Source

View the full FDA submission: accessdata.fda.gov

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Pre-Formed Penile Silicone Block

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