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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K012264
Device Name MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC
Applicant
National Custom Ent., Inc.
1133 E. Cliff Rd.
Burnsville,  MN  55337
Applicant Contact DON PELLETIER
Correspondent
National Custom Ent., Inc.
1133 E. Cliff Rd.
Burnsville,  MN  55337
Correspondent Contact DON PELLETIER
Regulation Number870.2340
Classification Product Code
DPS  
Date Received07/18/2001
Decision Date 10/10/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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