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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Electrode Recording, Or Probe, Electrode Recording
510(k) Number K904747
Device Name PEI PLAQUE ELECTRODE ARRAY
Applicant
Prucka Engineering, Inc.
8030 El Rio
Houston,  TX  77054
Applicant Contact STEVEN KIM
Correspondent
Prucka Engineering, Inc.
8030 El Rio
Houston,  TX  77054
Correspondent Contact STEVEN KIM
Regulation Number870.1220
Classification Product Code
DRF  
Date Received10/19/1990
Decision Date 10/09/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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