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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tester, pacemaker electrode function
510(k) Number K050884
Device Name ADAPTER CABLE
Applicant
REMINGTON MEDICAL, INC.
6830 MEADOWRIDGE CT.
ALPHARETTA,  GA  30005
Applicant Contact DON ROSVOLD
Correspondent
REMINGTON MEDICAL, INC.
6830 MEADOWRIDGE CT.
ALPHARETTA,  GA  30005
Correspondent Contact DON ROSVOLD
Regulation Number870.3720
Classification Product Code
DTA  
Date Received04/07/2005
Decision Date 05/19/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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