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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stethoscope, Electronic
510(k) Number K990809
Device Name CADISCOPE ELECTRONIC STETHOSCOPE
Applicant
Caditec AG
One Medical Pl.
Mundelein,  IL  60060
Applicant Contact BETTY LOCK
Correspondent
Caditec AG
One Medical Pl.
Mundelein,  IL  60060
Correspondent Contact BETTY LOCK
Regulation Number870.1875
Classification Product Code
DQD  
Date Received03/11/1999
Decision Date 06/09/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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