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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Programmer, Pacemaker
510(k) Number K844484
Device Name HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEA
Applicant
Vitatron Medical BV
P.O. Box 76
6950 Ab
Dieren,  NL
Applicant Contact RENIRIE
Correspondent
Vitatron Medical BV
P.O. Box 76
6950 Ab
Dieren,  NL
Correspondent Contact RENIRIE
Regulation Number870.3700
Classification Product Code
KRG  
Date Received11/19/1984
Decision Date 07/24/1985
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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