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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, penile
510(k) Number K953640
Device Name DUNA II PENILE PROSTHESIS
Applicant
DACOMED CORP.
1701 E. 79TH ST., STE. 17
minneapolis,  MN  55425
Applicant Contact mary m wilen
Correspondent
DACOMED CORP.
1701 E. 79TH ST., STE. 17
minneapolis,  MN  55425
Correspondent Contact mary m wilen
Regulation Number876.3630
Classification Product Code
FAE  
Date Received08/04/1995
Decision Date 10/27/1995
Decision substantially equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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