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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cystometer, Electrical Recording
510(k) Number K880391
Device Name DACOMED CYSTOMETER
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 Number876.1620
Classification Product Code
EXQ  
Date Received01/29/1988
Decision Date 04/27/1988
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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