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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 K993343
Device Name ERECXEL ADJUSTABLE PENILE BANDS, CONTREX ADJUSTABLE PENILE BANDS
Applicant
Erecxel Enterprises
3249 San Femando Rd.
Los Angeles,  CA  90065
Applicant Contact PACIFICO R BURGOS
Correspondent
Erecxel Enterprises
3249 San Femando Rd.
Los Angeles,  CA  90065
Correspondent Contact PACIFICO R BURGOS
Regulation Number876.5020
Classification Product Code
LKY  
Date Received10/05/1999
Decision Date 03/20/2000
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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