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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, External Penile Rigidity
510(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.
24 Carpenter Rd.
New York,  NY  10918
Applicant Contact ANDREW I SEALFON
Correspondent
Repro-Med Systems, Inc.
24 Carpenter Rd.
New York,  NY  10918
Correspondent Contact ANDREW I SEALFON
Regulation Number876.5020
Classification Product Code
LKY  
Date Received04/27/1998
Decision Date 06/25/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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