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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pulse-Generator, Pacemaker, External
510(k) Number K001180
Device Name TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528
Applicant
PACE MEDICAL
391 TOTTEN POND RD.
WALTHAM,  MA  02451
Applicant Contact ROBERT C MACE
Correspondent
PACE MEDICAL
391 TOTTEN POND RD.
WALTHAM,  MA  02451
Correspondent Contact ROBERT C MACE
Regulation Number870.3600
Classification Product Code
DTE  
Date Received04/11/2000
Decision Date 06/27/2000
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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