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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pacemaker Lead Adaptor
510(k) Number K843060
Device Name SENTRA
Applicant
CARDIAC PACEMAKERS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
CARDIAC PACEMAKERS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number870.3620
Classification Product Code
DTD  
Date Received08/03/1984
Decision Date 09/20/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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