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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 K003452
Device Name POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D
Applicant
Ep Technologies, Inc.
2710 Orchard Pkwy.
San Jose,  CA  95134
Applicant Contact CHRISTINA ROWE
Correspondent
Ep Technologies, Inc.
2710 Orchard Pkwy.
San Jose,  CA  95134
Correspondent Contact CHRISTINA ROWE
Regulation Number870.1220
Classification Product Code
DRF  
Date Received11/07/2000
Decision Date 12/07/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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