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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K914970
Device Name CARDIOVIT CS-100
Applicant
Schiller America, Inc.
3002 Dow Ave. #122
Tustin,  CA  92680
Applicant Contact MARKUS MARITZ
Correspondent
Schiller America, Inc.
3002 Dow Ave. #122
Tustin,  CA  92680
Correspondent Contact MARKUS MARITZ
Classification Product Code
LOS
Date Received11/05/1991
Decision Date 11/03/1992
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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