Name: Predicase
Price: 199 USD

K-number	K981506
Device name	RESTORE VACUUM ERECTION DEVICE, CONFIDE VACUUM ERECTION DEVICE, PEP (PENILE ERECTION PROGRAM), RELY VACUUM ERECTION DEV)
Applicant	Repro-Med Systems, Inc.
Product code	LKY
Device class	Class II
Decision date	Jun 25, 1998
Decision	Substantially Equivalent
Regulation	876.5020

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View the full FDA submission: accessdata.fda.gov

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RESTORE VACUUM ERECTION DEVICE, CONFIDE VACUUM ERECTION DEVICE, PEP (PENILE ERECTION PROGRAM), RELY VACUUM ERECTION DEV)

Everything you need for a 510(k) submission. Nothing you don't.