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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., Suite 17
Minneapolis,  MN  55425
Applicant Contact MARY M WILEN
Correspondent
Dacomed Corp.
1701 E. 79th St., Suite 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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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