RESTORE VACUUM ERECTION DEVICE, CONFIDE VACUUM ERECTION DEVICE, PEP (PENILE ERECTION PROGRAM), RELY VACUUM ERECTION DEV)— 510(k) K981506
Substantially EquivalentRepro-Med Systems, Inc.
FDA 510(k) clearance K981506 for RESTORE VACUUM ERECTION DEVICE, CONFIDE VACUUM ERECTION DEVICE, PEP (PENILE ERECTION PROGRAM), RELY VACUUM ERECTION DEV), Substantially Equivalent on 1998-06-25. Applicant: Repro-Med Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Repro-Med Systems, Inc.
- Product code
- Code LKY
- Device class
- Class 2
- Regulation
- 21 CFR 876.5020
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New York, NY, US
Recent devices under product code LKY
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