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FDA 510(k), K843280, MALLEABLE PENILE PROSTHESIS
FDA 510(k), K843280, MALLEABLE PENILE PROSTHESIS
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510(K) Number: K843280
Device Name: MALLEABLE PENILE PROSTHESIS
Manufacturer: MENTOR CORP.
Device Classification Name: prosthesis, penile
Regulation Number: 876.3630
Classification Product Code: FAE
Date Received: 08/20/1984
Decision Date: 10/24/1984
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: MALLEABLE PENILE PROSTHESIS
Manufacturer: MENTOR CORP.
Device Classification Name: prosthesis, penile
Regulation Number: 876.3630
Classification Product Code: FAE
Date Received: 08/20/1984
Decision Date: 10/24/1984
Regulation Medical Specialty: Gastroenterology/Urology
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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