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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cable, Transducer And Electrode, Patient, (Including Connector)
510(k) Number K080605
Device Name SURE-LOCK ELECTRODE CLIP, MODEL CL-34, CL-A60, CL-HW, CL-TL
Applicant
Curbell Electronics, Inc.
20 Centre Dr.
Orchard Park,  NY  14127
Applicant Contact MICHAEL J WINTER
Correspondent
Curbell Electronics, Inc.
20 Centre Dr.
Orchard Park,  NY  14127
Correspondent Contact MICHAEL J WINTER
Regulation Number870.2900
Classification Product Code
DSA  
Date Received03/04/2008
Decision Date 05/05/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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