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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 K940323
Device Name ARBO DIAGNOSTIC ECG PATIENT CABLES & LEADWIRES ARBO SHIELDED MULTI-LEAD CABLE & LEAD SYSTEM
Applicant
Arbo Medical, Inc.
300 Long Beach Blvd.
Stratford,  CT  06497
Applicant Contact WAYNE D SHOCKLOSS
Correspondent
Arbo Medical, Inc.
300 Long Beach Blvd.
Stratford,  CT  06497
Correspondent Contact WAYNE D SHOCKLOSS
Regulation Number870.2900
Classification Product Code
DSA  
Date Received01/24/1994
Decision Date 04/12/1995
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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