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FDA 510(k) Application Details - K993343

Device Classification Name Device, External Penile Rigidity

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510(K) Number K993343
Device Name Device, External Penile Rigidity
Applicant ERECXEL ENTERPRISES
3249 SAN FEMANDO RD.
LOS ANGELES, CA US
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Contact PACIFICO R BURGOS
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Regulation Number 876.5020

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Classification Product Code LKY
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Date Received 10/05/1999
Decision Date 03/20/2000
Decision SE - Substantially Equivalent
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review N



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