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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector And Syringe, Angiographic
510(k) Number K923117
Device Name CAVERNOSOMETRY MODULE FOR MENUET
Applicant
Dantec Medical, Inc.
1575 Eye St. NW
Washington,  DC  20005
Applicant Contact RICHARD D MANTHEI
Correspondent
Dantec Medical, Inc.
1575 Eye St. NW
Washington,  DC  20005
Correspondent Contact RICHARD D MANTHEI
Regulation Number870.1650
Classification Product Code
DXT  
Date Received06/26/1992
Decision Date 02/22/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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