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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K922898
Device Name CARDIO PERFECT, CARDIO PERFECT MD
Applicant
Cardio Control BV
Partrijsweg 72
2289 Ex Rijswijk
The Netherlands,  NL
Applicant Contact VAN LUIJK
Correspondent
Cardio Control BV
Partrijsweg 72
2289 Ex Rijswijk
The Netherlands,  NL
Correspondent Contact VAN LUIJK
Classification Product Code
LOS
Date Received06/16/1992
Decision Date 11/01/1993
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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