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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 K920409
Device Name DACOMED BATTERY OPERATED VACUUM ERECTION DEVICE
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 Number876.5020
Classification Product Code
LKY  
Date Received01/31/1992
Decision Date 05/11/1992
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
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